Data / Medical devices / United States / Microbiologics, Inc.
Microbiologics, Inc.: FDA-registered device maker in Saint Cloud, MN, United States, 6 510(k) clearances
Microbiologics, Inc. is registered with the FDA (registration 2150138) in Saint Cloud, MN, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 7, 2019. 44 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2150138
- Address
- 200 Cooper Avenue North, Saint Cloud, MN, United States, 56303
- Owner or operator
- MICROBIOLOGICS, INC. (2150138)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 4, 2005
- Registered through
- 2027
- Brand names listed
- 100111 India Ink, Positive Control, 100112 India Ink, Negative Control, 100114 India Ink, 100115 India Ink Kit, 5225P Gram-Positive Blood Culture Control Panel (Live Culture), 5246P Anaerobe Identification Panel, 5247P Gram Negative Identification Panel, 5248P Gram Positive Identification Panel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | 2 | Manufacturer | accessdata.fda.gov |
| Device, General Purpose, Microbiology, Diagnostic | LIB | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Quality Control For Culture Media | JTR | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Quality Control Slides | LJG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stains, Microbiologic | JTS | 1 | Manufacturer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2019 | K190086 | Cepheid Xpert Respiratory Control Panel | PMN | Substantially Equivalent | Microbiologics, Inc. | accessdata.fda.gov |
| June 25, 2019 | K191168 | Cepheid Xpert SA Nasal Complete Control Panel | PMN | Substantially Equivalent | Microbiologics, Inc. | accessdata.fda.gov |
| June 20, 2019 | K191172 | Cepheid Xpert MRSA NxG Control Panel | PMN | Substantially Equivalent | Microbiologics, Inc. | accessdata.fda.gov |
| May 8, 2019 | K190223 | Cepheid Xpert CT/NG Control Panel | PMN | Substantially Equivalent | Microbiologics, Inc. | accessdata.fda.gov |
| April 19, 2019 | K190463 | Cepheid Xpert C. difficile/Epi Control Panel | PMN | Substantially Equivalent | Microbiologics, Inc. | accessdata.fda.gov |
| August 15, 2018 | K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | PMN | Substantially Equivalent | Microbiologics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 2, 2025 | 98079 | Class II | Ongoing | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. | accessdata.fda.gov |
| November 13, 2025 | 97987 | Class II | Ongoing | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | accessdata.fda.gov |
| June 27, 2025 | 97168 | Class II | Ongoing | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack) | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. | accessdata.fda.gov |
| June 17, 2025 | 97096 | Class II | Ongoing | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient. | accessdata.fda.gov |
| May 27, 2025 | 96974 | Class II | Ongoing | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493 | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis. | accessdata.fda.gov |
| February 20, 2025 | 96382 | Class II | Ongoing | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | accessdata.fda.gov |
| February 20, 2025 | 96381 | Class II | Ongoing | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N | The RSV target may give a late Ct value and could potentially not pass QC. | accessdata.fda.gov |
| January 20, 2025 | 96166 | Class II | Ongoing | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test | Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays. | accessdata.fda.gov |
| March 6, 2024 | 94201 | Class II | Ongoing | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material. | accessdata.fda.gov |
| January 8, 2024 | 93801 | Class II | Ongoing | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control. | accessdata.fda.gov |
| October 18, 2023 | 93267 | Class II | Ongoing | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) | A complaint investigation showed that the bulk pellets (lot ) were contaminated with Aspergillus flavus. | accessdata.fda.gov |
| August 14, 2023 | 92878 | Class III | Ongoing | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. | accessdata.fda.gov |
| July 27, 2022 | 90761 | Class III | Terminated | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N | Product not registered for use in the UK | accessdata.fda.gov |
| May 6, 2022 | 90150 | Class III | Terminated | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | accessdata.fda.gov |
| March 24, 2022 | 89886 | Class II | Terminated | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | QC process was not adequate for the specification range. | accessdata.fda.gov |
| March 22, 2022 | 89887 | Class II | Terminated | Inactivated macrolide-resistant Mycoplasma genitalium | The QC process was not adequate for the specification range. | accessdata.fda.gov |
| March 3, 2022 | 89746 | Class II | Terminated | Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. | accessdata.fda.gov |
| February 25, 2022 | 89694 | Class II | Terminated | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Distributed product did not undergo proper release testing. | accessdata.fda.gov |
| August 20, 2021 | 88578 | Class II | Terminated | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. | accessdata.fda.gov |
| August 20, 2021 | 88577 | Class II | Terminated | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). | accessdata.fda.gov |
| February 24, 2021 | 89380 | Class III | Terminated | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls. | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | accessdata.fda.gov |
| February 24, 2021 | 89379 | Class III | Terminated | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls. | Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | accessdata.fda.gov |
| December 16, 2020 | 89384 | Class III | Terminated | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM) | The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022. | accessdata.fda.gov |
| December 16, 2020 | 89285 | Class II | Terminated | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299. | Contamination with S. epidermidis | accessdata.fda.gov |
| October 8, 2020 | 89386 | Class III | Terminated | KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) | The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label. | accessdata.fda.gov |
| October 8, 2020 | 86576 | Class II | Terminated | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moistur | KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. | accessdata.fda.gov |
| October 8, 2020 | 86574 | Class II | Terminated | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for | Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. | accessdata.fda.gov |
| October 1, 2020 | 89391 | Class II | Terminated | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o | Potential contamination with S. epidermidis E. coli and S. warneri. | accessdata.fda.gov |
| February 18, 2020 | 89401 | Class II | Terminated | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299 | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. | accessdata.fda.gov |
| February 12, 2020 | 85009 | Class II | Terminated | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3) | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis. | accessdata.fda.gov |
| January 3, 2020 | 84634 | Class II | Terminated | Vaginal Verification Panel Ref 8208 Lot 8208-11 | Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this | accessdata.fda.gov |
| December 16, 2019 | 84524 | Class II | Terminated | Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may ar | The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer. | accessdata.fda.gov |
| May 16, 2019 | 82787 | Class III | Ongoing | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | accessdata.fda.gov |
| April 9, 2019 | 82783 | Class II | Ongoing | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requestin | Product with incorrect shelf life. | accessdata.fda.gov |
| January 31, 2019 | 82077 | Class II | Terminated | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. | accessdata.fda.gov |
| June 6, 2017 | 89446 | Class II | Terminated | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, | Real-time shelf life testing failed at 24 months | accessdata.fda.gov |
| March 2, 2017 | 89412 | Class III | Terminated | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is s | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | accessdata.fda.gov |
| December 1, 2015 | 89517 | Class II | Terminated | QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived fro | The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the | accessdata.fda.gov |
| July 17, 2015 | 89513 | Class III | Completed | LYFO Disk | LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results. | accessdata.fda.gov |
| October 6, 2014 | 89451 | Class II | Terminated | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299 | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. | accessdata.fda.gov |
| March 25, 2013 | 89479 | Class III | Terminated | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM) | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism. | accessdata.fda.gov |
| February 11, 2013 | 64469 | Class II | Terminated | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents. | Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well wit | accessdata.fda.gov |
| May 29, 2012 | 61998 | Class II | Terminated | Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope | Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and impro | accessdata.fda.gov |
| October 12, 2007 | 45442 | Not yet classified | Terminated | MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P) | Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris. | accessdata.fda.gov |
Compare with other makers
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Updated December 22, 2025. 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.