Data / Medical devices / United States / Remel, Inc.
Remel, Inc.: FDA-registered device maker in Lenexa, KS, United States, 143 510(k) clearances
Remel, Inc. is registered with the FDA (registration 1924669) in Lenexa, KS, United States. It lists 73 device types. The FDA files 143 510(k) clearances under its listings, the newest dated September 5, 2025. 74 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1924669
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, United States, 66215
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- June 21, 1978
- Registered through
- 2026
- Brand names listed
- 100% Dehydrant, 20% Buffered Formalin, 60% Dehydrant, 70% Dehydrant, 7102-44 VERSATREK REDOX 1, 80 ML W/STIR BAR, 7103-44 VERSATREK REDOX 2, 80ML, 7103-44M VERSATREK REDOX 2M 80ML, 7104-44 VERSATREK REDOX 80ML TWIN-PACK and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 143.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2025 | K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| May 1, 2017 | K162620 | Remel Spectra ESBL | JSO | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| February 27, 2014 | K133773 | SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM | JWY | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| January 31, 2014 | K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| November 16, 2011 | K112276 | VIZION | JWY | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| September 22, 2011 | K110583 | SENSITITRE OPTIREAD | LRG | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| August 18, 2011 | K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... | JWY | Substantially Equivalent | Trek Diagnostic Systems, Ltd. | accessdata.fda.gov |
| June 22, 2011 | K103456 | THE SENSITITRE AIM | LIE | Substantially Equivalent | Trek Diagnostic Systems | accessdata.fda.gov |
| October 8, 2010 | K092407 | REMEL SPECTRA MRSA | JSO | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| July 15, 2010 | K092819 | REMEL SPECTRA VRE | JSO | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| August 26, 2009 | K092423 | XPECT FLU A & B | PSZ | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| June 4, 2009 | K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | NGZ | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| November 26, 2007 | K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | MJE | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| June 23, 2006 | K061301 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | JTW | Substantially Equivalent | Copan Diagnostics, Inc. | accessdata.fda.gov |
| January 19, 2006 | K052323 | VERSATREK MYCO PZA KIT | MJA | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| November 15, 2004 | K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | LLH | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| November 18, 2003 | K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | MHI | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| November 14, 2003 | K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | MHJ | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| November 10, 2003 | K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | MHI | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| August 22, 2003 | K032306 | VERSATREK | MDB | Substantially Equivalent | Trek Diagnostic Systems, Inc. | accessdata.fda.gov |
| July 17, 2003 | K031565 | XPECT INFLUENZA A/B | PSZ | Substantially Equivalent | Remel, Inc. | accessdata.fda.gov |
| August 28, 1997 | K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | JSO | Substantially Equivalent | Remel, L.P. | accessdata.fda.gov |
| February 7, 1997 | K964315 | REMEL STAPH LATEX KIT | JWX | Substantially Equivalent | Remel, L.P. | accessdata.fda.gov |
| October 8, 1996 | K962966 | IDS RAPID CB PLUS SYSTEM | JTO | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| September 18, 1996 | K961046 | 10B ARGININE BROTH | JSM | Substantially Equivalent | Remel, L.P. | accessdata.fda.gov |
| April 3, 1996 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | Substantially Equivalent | Starplex Scientific, Inc. | accessdata.fda.gov |
| March 25, 1996 | K960313 | MUELLER HINTON AGAR WITH 2% NACI | JTZ | Substantially Equivalent | Remel, L.P. | accessdata.fda.gov |
| March 19, 1996 | K960095 | BACTIDROP CALCOFLUOR WHITE | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| March 19, 1996 | K960090 | CALCOFLUOR WHITE STAIN KIT | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| February 16, 1996 | K954986 | GC BASE W/ 1% GCHI | JTY | Substantially Equivalent | Remel, L.P. | accessdata.fda.gov |
| February 16, 1995 | K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | JSL | Substantially Equivalent | Starplex Scientific, Inc. | accessdata.fda.gov |
| January 27, 1995 | K943621 | RAPID YEAST PLUS SYSTEM | JXB | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| November 30, 1994 | K943499 | KULTSURE STARSWAB(M240), MODIFICATION | JSM | Substantially Equivalent | Ncs Diagnostics, Inc. | accessdata.fda.gov |
| October 21, 1994 | K941579 | MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) | JSM | Substantially Equivalent | Microtest | accessdata.fda.gov |
| September 19, 1994 | K941444 | BHI AGAR WITH VANCOMYCIN | JSO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 19, 1994 | K941443 | SYNERGY QUAD | JSO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| May 20, 1994 | K936021 | BACTICARD STREP | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| April 20, 1994 | K933457 | RIM E.COLI 0157:H7 LATEX TEST | GNA | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| February 25, 1994 | K935124 | BACTICARD CANDIDA | JXB | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| February 23, 1994 | K934986 | BACTICARD E. COLI | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 15, 1993 | K931383 | ZINC PVA | LIO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| November 2, 1992 | K923566 | NIZYME TEST KIT | JSX | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| October 5, 1992 | K923700 | INDOXYL ACETATE DISK | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 28, 1992 | K923827 | LAP DISK | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 29, 1992 | K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM | LJZ | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 19, 1992 | K920974 | BACTIDROP ACRIDINE ORANGE | JFO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 19, 1992 | K920973 | BACTIDROP INDOLE (ERLICH'S) | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 9, 1992 | K920976 | BACTIDROP INDIA INK | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 9, 1992 | K920970 | BACTIDROP KOH (10%) | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| May 22, 1992 | K920971 | BACTIDROP NINHYDRIN | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| May 6, 1992 | K921472 | M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION) | JSM | Substantially Equivalent | Microtest | accessdata.fda.gov |
| April 22, 1992 | K920257 | NIACIN CONTROL DISKS | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 23, 1991 | K913008 | BACTIDROP(TM) OXIDASE | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 23, 1991 | K913007 | BACTIDROP(TM) VOGES-PROSKAUER B | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 23, 1991 | K913006 | BACTIDROP(TM) DOBELL & O'CONNOR IODINE | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 23, 1991 | K913003 | BACTIDROP(TM) VOGES-PROSKAUER A | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 23, 1991 | K913002 | BACTIDROP(TM) FERRIC CHLORIDE (10%) | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 19, 1991 | K913011 | BACTIDROP(TM) NITRATE A | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 19, 1991 | K913010 | BACTIDROP (TM) NITRATE B | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 18, 1991 | K913009 | BACTIDROP(TM) INDOLE (KOVACS) | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 18, 1991 | K913004 | BACTIDROP(TM) SPOT INDOLE | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 18, 1991 | K913001 | BACTIDROP(TM) DESOXYCHOLATE (10%) | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 16, 1991 | K913005 | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE | JIO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| April 9, 1991 | K910526 | MICROTEST MULTI MICROBE MEDIUM | JSM | Substantially Equivalent | Microtest | accessdata.fda.gov |
| February 27, 1991 | K905472 | LAP DISCS | JTO | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. | accessdata.fda.gov |
| February 20, 1991 | K905163 | NITRATE DISK | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| January 25, 1991 | K905151 | VANCOMYCIN DISK-5 MCG | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| October 2, 1990 | K902595 | CATARRHALIS TEST STRIP | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 28, 1990 | K902541 | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX | KTN | Substantially Equivalent | Trinity Laboratories, Inc. | accessdata.fda.gov |
| March 13, 1990 | K900517 | RAPID NF SYSTEM | JSW | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| December 5, 1989 | K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 | LJM | Substantially Equivalent | General Biometrics, Inc. | accessdata.fda.gov |
| September 6, 1989 | K894848 | HAEMOPHILUS TEST MEDIUM (BROTH) | JSO | Substantially Equivalent | Regional Media Laboratories | accessdata.fda.gov |
| June 13, 1989 | K892928 | HAEMOPHILUS TEST MEDIUM (AGAR) | JSO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 2, 1989 | K884720 | GERM TUBE SOLUTION | JXC | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| May 4, 1989 | K883641 | SELECTIVE RAPID UREA | LYR | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| April 12, 1989 | K891476 | C. ALBICANS SCREEN | JXC | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. | accessdata.fda.gov |
| February 16, 1989 | K882636 | ALN DISCS | JTO | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. | accessdata.fda.gov |
| February 16, 1989 | K882630 | PRO DISCS | JTO | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. | accessdata.fda.gov |
| August 12, 1988 | K882960 | IDS RAPID ANA SYSTEM | JSP | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| June 2, 1988 | K881995 | DIAMOND'S MEDIUM MODIFIED | KZI | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| May 18, 1988 | K881501 | MODIFIED IDS RAPID NH SYSTEM | JSX | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| April 7, 1988 | K881247 | MONO-PHILE | KTN | Substantially Equivalent | Bio Diagnostic Systems, Inc. | accessdata.fda.gov |
| April 1, 1988 | K880950 | PYR/ESCULIN DISK | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| July 29, 1987 | K872189 | METHANOL, ABSOLUTE | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| July 29, 1987 | K872187 | TB KINYOUN CARBOLFUCHSIN | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| July 29, 1987 | K872186 | SULFURIC ACID 10% | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| July 29, 1987 | K872184 | TB METHYLENE BLUE | JTS | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| June 24, 1987 | K872188 | MACCONKEY W/SORBITOL | JSI | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| May 13, 1987 | K871447 | TODD HEWITT W/CNA (LIM BROTH) | JSD | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| April 8, 1987 | K871286 | GRAM IODINE | HYI | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| September 15, 1986 | K863216 | NEIS NZY | JTO | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. | accessdata.fda.gov |
| March 11, 1986 | K860707 | OFPBL | JSI | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| February 5, 1986 | K860302 | PYR DISCS | JTO | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. | accessdata.fda.gov |
| July 23, 1985 | K852886 | MUG DISK | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| July 23, 1985 | K852871 | IDS RAPID SS/U SYSTEM | JSS | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| June 4, 1985 | K852110 | IDS RAPID E PLUS SYSTEM | JSS | Substantially Equivalent | Innovative Diagnostic Systems, Inc. | accessdata.fda.gov |
| May 10, 1985 | K850291 | MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS | JTZ | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| April 22, 1985 | K850194 | CAFFEIC ACID DISK | JSF | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| December 13, 1984 | K844020 | PYRIDOXAL DISC | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
| October 30, 1984 | K843987 | PYR BROTH | JTO | Substantially Equivalent | Remel Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 3, 2026 | 99132 | Class II | Ongoing | GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 | Reduced or no recovery of some strains of Neisseria gonorrhoeae. | accessdata.fda.gov |
| March 24, 2026 | 98616 | Class II | Ongoing | Yeastone Broth, 11ML, 10/BOX YY3462 | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. | accessdata.fda.gov |
| February 5, 2026 | 98403 | Class II | Ongoing | Campy CVA Medium 100/PK, R01272 | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. | accessdata.fda.gov |
| November 12, 2025 | 97967 | Class II | Ongoing | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 | Products may contain contamination, which may result in a darker or brown media color. | accessdata.fda.gov |
| July 11, 2025 | 97224 | Class II | Ongoing | Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | accessdata.fda.gov |
| May 1, 2025 | 96810 | Class II | Ongoing | Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device | Product may have an off color affecting perfomance | accessdata.fda.gov |
| February 13, 2025 | 96312 | Class II | Ongoing | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. | accessdata.fda.gov |
| February 12, 2025 | 96278 | Class II | Ongoing | Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. | accessdata.fda.gov |
| September 20, 2024 | 95458 | Class II | Ongoing | remel BactiDrop Acridine Orange, REF 21502, 50 per package. | A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results. | accessdata.fda.gov |
| August 14, 2023 | 92880 | Class II | Ongoing | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples | accessdata.fda.gov |
| May 31, 2023 | 92444 | Class II | Ongoing | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. | The test medium may not perform as intended. | accessdata.fda.gov |
| October 20, 2022 | 91104 | Class I | Terminated | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | accessdata.fda.gov |
| January 10, 2022 | 89416 | Class II | Terminated | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format | There are lower than expected MICs for some gram negative species. | accessdata.fda.gov |
| June 18, 2021 | 88205 | Class II | Terminated | ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom | Out of Specification | accessdata.fda.gov |
| April 22, 2021 | 87830 | Class II | Terminated | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-res | The media allows growth of E. faecalis ATCC 29212 with blackening of the media. | accessdata.fda.gov |
| March 10, 2021 | 87495 | Class II | Ongoing | Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure. | accessdata.fda.gov |
| December 10, 2020 | 87010 | Class II | Terminated | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 | The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. | accessdata.fda.gov |
| April 17, 2019 | 82683 | Class II | Terminated | Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | accessdata.fda.gov |
| April 17, 2019 | 82677 | Class II | Terminated | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days. | accessdata.fda.gov |
| August 13, 2018 | 80813 | Class II | Terminated | remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720 | Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. | accessdata.fda.gov |
| May 4, 2018 | 80068 | Class II | Terminated | remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- r | Product may fail performance testing for S aureus ATCC 43300. | accessdata.fda.gov |
| December 8, 2017 | 78728 | Class II | Terminated | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic p | The serum may fail to agglutinate within the specified minimum reaction time. | accessdata.fda.gov |
| November 2, 2017 | 78470 | Class II | Terminated | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Product may have incorrect cation information detailed on the product label. | accessdata.fda.gov |
| March 24, 2017 | 76846 | Class II | Terminated | Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide varie | Confirmed complaint of surface contamination of Listeria monocytogenes. | accessdata.fda.gov |
| February 9, 2017 | 76445 | Class II | Terminated | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033 | Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests. | accessdata.fda.gov |
| March 24, 2016 | 73658 | Class II | Terminated | Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic | Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting. | accessdata.fda.gov |
| November 6, 2015 | 72525 | Class II | Terminated | Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility | Antibiotic concentration may be insufficient which may result in incorrect test results. | accessdata.fda.gov |
| June 30, 2015 | 71614 | Class II | Terminated | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates. | A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species. | accessdata.fda.gov |
| May 19, 2015 | 71291 | Class II | Terminated | VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fl | Use of the recalled product may result in false positive reports. | accessdata.fda.gov |
| May 4, 2015 | 71198 | Class II | Terminated | Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wi | Product may be contaminated with Listeria monocytogenes. | accessdata.fda.gov |
| February 5, 2015 | 70471 | Class II | Terminated | Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England. | Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila. | accessdata.fda.gov |
| November 13, 2014 | 69771 | Class II | Terminated | Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella. | Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting. | accessdata.fda.gov |
| October 29, 2014 | 69629 | Class II | Terminated | Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria. | The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease. | accessdata.fda.gov |
| October 23, 2014 | 69566 | Class II | Terminated | Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a | A reagent within the test may return false negative results. | accessdata.fda.gov |
| October 17, 2014 | 69521 | Class II | Terminated | Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella. | Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila. | accessdata.fda.gov |
| June 11, 2014 | 68583 | Class II | Terminated | Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS. | Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae. | accessdata.fda.gov |
| March 17, 2014 | 67777 | Class II | Terminated | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxo | A reagent contained within the product may return false negative results. | accessdata.fda.gov |
| February 18, 2014 | 67590 | Class II | Terminated | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for i | Some of the discs may not be impregnated with the antibiotic. | accessdata.fda.gov |
| January 24, 2014 | 67415 | Class II | Terminated | Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of | The product may contain high levels of microbial contamination | accessdata.fda.gov |
| November 21, 2013 | 67099 | Class II | Terminated | Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United | Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes. | accessdata.fda.gov |
| May 2, 2013 | 65476 | Class II | Terminated | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., | The product may give weak or false negative test results. | accessdata.fda.gov |
| April 9, 2013 | 65184 | Class II | Terminated | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the s | Cartridges may contain individual discs which were not impregnated with antibiotic. | accessdata.fda.gov |
| April 4, 2013 | 65477 | Class II | Terminated | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed. | accessdata.fda.gov |
| March 25, 2013 | 64852 | Class III | Terminated | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | accessdata.fda.gov |
| February 19, 2013 | 64711 | Class III | Terminated | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. | accessdata.fda.gov |
| November 21, 2012 | 65734 | Class III | Terminated | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative a | Boxes labeled as CIP5 may contain cartridges of AMP5. | accessdata.fda.gov |
| October 10, 2012 | 63584 | Class II | Terminated | The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples. | The product may contain low level microbial contamination which could result in incorrect results. | accessdata.fda.gov |
| August 21, 2012 | 63556 | Class II | Terminated | Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK. | The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic. | accessdata.fda.gov |
| August 21, 2012 | 63555 | Class II | Terminated | Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc | The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation back of receipt. | accessdata.fda.gov |
| August 20, 2012 | 63558 | Class II | Terminated | Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detecti | The firm is recalling the products due to a potential for false negative test results. | accessdata.fda.gov |
| May 11, 2011 | 59005 | Not yet classified | Terminated | Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS. The product is a selective and differential chromogenic medium recommended f | The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA) | accessdata.fda.gov |
| April 21, 2011 | 58684 | Not yet classified | Terminated | remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the | Organism strains may fail to consistently produce confluent growth | accessdata.fda.gov |
| January 18, 2010 | 54281 | Not yet classified | Terminated | remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product i | Pouch may be inadequately heat sealed compromising sterility | accessdata.fda.gov |
| December 21, 2009 | 54194 | Not yet classified | Terminated | Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious or | Product failure - Failure to grow quality control strains of Streptococcus pneumoniae. | accessdata.fda.gov |
| December 8, 2009 | 54042 | Not yet classified | Terminated | remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. The product is a solid medium recommended for use in qualitative procedures to screen Staphyl | The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591. | accessdata.fda.gov |
| October 28, 2009 | 53800 | Not yet classified | Terminated | ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the i | There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between Candida albicans and | accessdata.fda.gov |
| July 20, 2009 | 53553 | Not yet classified | Terminated | Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping fac | The products may give false positive results with some non-Staphylococcus aureus strains | accessdata.fda.gov |
| May 7, 2009 | 52160 | Not yet classified | Terminated | Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. Collection and transportation of clinical specimens to the laboratory for | Incorrect expiration date on the product | accessdata.fda.gov |
| May 6, 2009 | 52111 | Not yet classified | Terminated | Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobac | The plate labeling is incorrect, but the outer box labeling is correct | accessdata.fda.gov |
| November 18, 2008 | 51131 | Not yet classified | Terminated | Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Euro | These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus. | accessdata.fda.gov |
| October 7, 2008 | 50224 | Not yet classified | Terminated | Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found i | Control and test wells are reversed on some of the reaction cards. | accessdata.fda.gov |
| August 11, 2008 | 49090 | Not yet classified | Terminated | Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens. | Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive | accessdata.fda.gov |
| October 23, 2007 | 46801 | Not yet classified | Terminated | Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215 | Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions. | accessdata.fda.gov |
| February 21, 2007 | 37423 | Not yet classified | Terminated | Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS. | False negative results for sorbitol fermenting bacteria such as E. Coli 0157. | accessdata.fda.gov |
| February 14, 2006 | 34612 | Not yet classified | Terminated | Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England | Some units exhibit weak false-positive reactions with some negative patient serum | accessdata.fda.gov |
| September 27, 2004 | 30154 | Not yet classified | Terminated | Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS. | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) | accessdata.fda.gov |
| December 9, 2003 | 29680 | Not yet classified | Terminated | ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496. | The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run. | accessdata.fda.gov |
| November 3, 2003 | 27713 | Not yet classified | Terminated | Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS. | Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area | accessdata.fda.gov |
| October 2, 2003 | 27473 | Not yet classified | Terminated | Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS. | Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae | accessdata.fda.gov |
| December 5, 2002 | 25250 | Not yet classified | Terminated | REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS. | Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks. | accessdata.fda.gov |
| November 21, 2002 | 29679 | Not yet classified | Terminated | ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496. | The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates. | accessdata.fda.gov |
| July 18, 2002 | 29677 | Not yet classified | Terminated | ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fe | A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. | accessdata.fda.gov |
| July 15, 2002 | 29672 | Not yet classified | Terminated | ProSpecT Campylobacter Microplate Assay. Catalog #2476096. | A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. | accessdata.fda.gov |
| May 9, 2002 | 29681 | Not yet classified | Terminated | ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096. | A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing | accessdata.fda.gov |
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Updated June 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.