Data / Medical devices / United States / Microgenics Corporation
Microgenics Corporation: FDA-registered device maker in Fremont, CA, United States, 103 510(k) clearances
Microgenics Corporation is registered with the FDA (registration 3010939897) in Fremont, CA, United States. It lists 67 device types. The FDA files 103 510(k) clearances under its listings, the newest dated December 11, 2024. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010939897
- Address
- 46500 Kato Road, Fremont, CA, United States, 94538
- Owner or operator
- Thermo Fisher Scientific (2517925)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- July 3, 2003
- Registered through
- 2026
- Brand names listed
- 125I T3 UPTAKE RADIOASSAY KIT, AEC Substrate System (RTU) 125mL, AEC Substrate System (RTU) 60mL, ALK (Anaplastic Lymphoma Kinase) / p80 0.1mL, ALK (Anaplastic Lymphoma Kinase) / p80 0.5mL, ALK (Anaplastic Lymphoma Kinase) / p80 1mL, ALK (Anaplastic Lymphoma Kinase) / p80 Ab-1 0.1mL, ALK (Anaplastic Lymphoma Kinase) / p80 Ab-1 0.5mL 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 103.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2024 | K243498 | Alinity c Benzodiazepines Reagent Kit | JXM | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| October 30, 2024 | K240670 | DRI Ecstasy Plus Assay | DKZ | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| November 17, 2023 | K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | LFH | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| September 27, 2023 | K231007 | CEDIA Heroin Metabolite (6-AM) Assay | DJG | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| December 21, 2022 | K213875 | DRI TM Tricyclics Serum Tox Assay | LFH | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| September 24, 2021 | K211973 | DRI Cocaine Metabolite Assay | DIO | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| December 9, 2019 | K190968 | CEDIA Benzodiazepine Assay | JXM | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| November 19, 2018 | DEN180030 | QMS Plazomicin Immunoassay | QDR | Unknown | Microgenics Corporation | accessdata.fda.gov |
| July 6, 2018 | K181499 | DRI Cocaine Metabolite Assay | DIO | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| February 21, 2018 | K173963 | DRI Benzodiazepine Assay | JXM | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| February 13, 2018 | K173195 | DRI Hydrocodone Assay | DJG | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| April 6, 2017 | K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set | DJG | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| August 20, 2013 | K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | OUF | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| July 11, 2013 | K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | MLM | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| June 5, 2013 | K123518 | ABBOTT CARBAMAZEPINE ASSAY | KLT | Substantially Equivalent | Microgenics Corporation | accessdata.fda.gov |
| April 26, 2013 | K123271 | ABBOTT PHENOBARBITAL ASSAY | DLZ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 8, 2011 | K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | DJG | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 8, 2011 | K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | LAF | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 8, 2011 | K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | LCM | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 8, 2011 | K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | DKZ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 8, 2011 | K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | LDJ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 8, 2011 | K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | DIO | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| February 4, 2011 | K103403 | MULTICONSTITUENT CALIBRATOR | JIX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 12, 2010 | K093114 | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY | DKZ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| May 29, 2009 | K090282 | QMS LIDOCAINE | KLR | Substantially Equivalent | Thermo Fisher Scientific, Inc. | accessdata.fda.gov |
| January 14, 2009 | K081378 | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS | DJR | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| December 19, 2008 | K081083 | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS | OAV | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| April 30, 2008 | K080085 | MAS TOX CONTROL | DIF | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| May 17, 2007 | K070645 | SERADYN QMS TOPIRAMATE | NWM | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| January 12, 2007 | K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | ORH | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| July 21, 2006 | K060998 | QMS TOBRAMYCIN | LCR | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| June 15, 2006 | K060709 | MULTIGENT GENTAMICIN | LCD | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| December 23, 2005 | K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | LBZ | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| November 18, 2005 | K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | NWM | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| November 1, 2005 | K052815 | QMS AMIKACIN REAGENTS | KLQ | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| April 1, 2005 | K050419 | QMS VANCOMYCIN | LEH | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| August 16, 2004 | K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | JJX | Substantially Equivalent | Medical Analysis Systems, Inc. | accessdata.fda.gov |
| June 23, 2004 | K040316 | CEDIA BUPRENORPHINE ASSAY | DJG | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| May 28, 2004 | K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT | DIF | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| May 27, 2004 | K040411 | DRI OXYCODONE ASSAY | LAS | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 27, 2003 | K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| May 22, 2003 | K030649 | DRI COTININE EIA ASSAY | MRS | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| April 28, 2003 | K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | LEG | Substantially Equivalent | Seradyn | accessdata.fda.gov |
| October 24, 2002 | K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | MKW | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| October 24, 2002 | K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | KXT | Substantially Equivalent | Seradyn | accessdata.fda.gov |
| December 21, 2001 | K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL | JJY | Substantially Equivalent | Medical Analysis Systems, Inc. | accessdata.fda.gov |
| August 27, 2001 | K012110 | DRI ECSTASY ENZYME IMMUNOASSAY | DKZ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 27, 2001 | K012109 | DRI ECSTASY URINE CALIBRATORS | DLJ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| June 20, 2001 | K011150 | DRIDAU OPIATE ASSAY | DJG | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| May 29, 2001 | K010496 | CEDIA DAU AMPHETAMINES/ECSTASY ASSAY | LAF | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| January 13, 1999 | K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM | PJD | Substantially Equivalent | Osborn Laboratories, Inc. | accessdata.fda.gov |
| November 5, 1998 | K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | DKB | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| July 9, 1998 | K981706 | AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 | JIX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 26, 1998 | K980746 | CEDIA DAU EDDP ASSAY | DJR | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| September 22, 1997 | K972963 | MODIFIED CEDIA DAU PCP ASSAY | LCM | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| August 4, 1997 | K972526 | METHADONE EIA ASSAY | DJR | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| November 20, 1996 | K963840 | CEDIA PHENYTOIN II ASSAY | DIP | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| October 30, 1996 | K962795 | CEDIA DAU OPIATE 2K ASSAY | DJG | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| October 29, 1996 | K963306 | CEDIA N-ACETYLPROCAINAMIDE ASSAY | LAR | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| October 29, 1996 | K962269 | CEDIA CARDIAC TDM MULTI-CALS | JIX | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| August 27, 1996 | K962099 | CEDIA PROCAINAMIDE ASSAY | LAR | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| July 8, 1996 | K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | LDP | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| June 27, 1996 | K961462 | CEDIA THEOPHYLLINE ASSAY | KLS | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| June 13, 1996 | K961659 | CEDIA CORE TDM MULTI-CAL | JIX | Substantially Equivalent | Boehringer Mannheim Corp. | accessdata.fda.gov |
| June 12, 1996 | K961393 | TRICYCLICS SERUM TOX ASSAY | LFH | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| May 20, 1996 | K960708 | BENZODIAZEPINE SERUM TOX EIA TEST | JXM | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| May 6, 1996 | K960664 | BARBITURATE SERUM TOX EIA ASSAY | DIS | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| May 1, 1996 | K961372 | SERUM TOX CALIBRATOR | DKB | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| April 2, 1996 | K960187 | COCAINE METABOLITE EIA TEST | DIO | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| March 11, 1996 | K955928 | BARBITURATE EIA ESSAY (MODIFICATION) | DIS | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| February 9, 1996 | K955814 | CEDIA DAU LSD ASSAY | DLB | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| November 17, 1995 | K954227 | CEDIA DAU METHADONE ASSAY | DJR | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 11, 1995 | K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY | KLS | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| May 2, 1995 | K951133 | CEDIA DAU PROPOXYPHENE ASSAY | JXN | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| February 10, 1995 | K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY | DLZ | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| February 3, 1995 | K945725 | PHENYTION EIA TEST | DIP | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| December 9, 1994 | K944703 | THYROXINE ENZYME IMMUNOASSAY | KLI | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| November 4, 1994 | K943998 | CANNABINOID EIA ASSAY | LDJ | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| October 20, 1994 | K943019 | CEDIA T4 MAB ASSAY | KLI | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| September 9, 1994 | K943414 | PROPOXPHENE EIA TEST | JXN | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| August 30, 1994 | K942436 | CEDIA DAU BARBITURATE ASSAY | DIS | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 1, 1994 | K942337 | CEDIA DAU MULTI-LEVEL THC ASSAY | LDJ | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| July 6, 1994 | K940935 | URINE CALIBRATOR | DKB | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| June 2, 1994 | K940376 | QMS GENTAMICIN ASSAY | LCD | Substantially Equivalent | Seradyn, Inc. | accessdata.fda.gov |
| May 3, 1994 | K940123 | METHAQUALONE ENZYME IMMUNOASSAY | KXS | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| March 11, 1994 | K935904 | CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS | DIO | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| January 11, 1994 | K935346 | CEDIA(R) DAU OPIATE ASSAY | DJG | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| December 29, 1993 | K935320 | PHENCYCLIDINE EIA ASSAY | LCM | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| September 21, 1993 | K930734 | CEDIA VALPORIC ACID ASSAY | LEG | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 5, 1993 | K930529 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| June 29, 1993 | K932113 | CANNABINOID URINE CONTROLS | JJX | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| January 21, 1993 | K923783 | ETHYL ALCOHOL ASSAY | DMT | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| December 9, 1992 | K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL | DNN | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| September 14, 1992 | K923386 | THC URINE CALIBRATORS | DLJ | Substantially Equivalent | Diagnostic Reagents, Inc. | accessdata.fda.gov |
| January 15, 1992 | K914857 | CEDIA(R) CARBAMAZEPINE ASSAY | KLT | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| September 27, 1991 | K913470 | CEDIA(R) GENTAMICIN ASSAY | LCD | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| July 26, 1991 | K912143 | CEDIA(R) TOBRAMYCIN ASSAY | LFW | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| August 22, 1990 | K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET | DLJ | Substantially Equivalent | Innotron of Oregon, Inc. | accessdata.fda.gov |
| November 8, 1989 | K896021 | CEDIA DIGITOXIN ASSAY | LFM | Substantially Equivalent | Microgenics Corp. | accessdata.fda.gov |
| July 21, 1987 | K872644 | INNOFLUOR VANCOMYCIN CALIBRATOR SET | DLJ | Substantially Equivalent | Innotron of Oregon, 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 |
|---|---|---|---|---|---|---|
| August 17, 2026 | 99736 | Class II | Ongoing | MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP | Vial-to-vial variability in MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results. | accessdata.fda.gov |
| October 1, 2025 | 97745 | Class II | Ongoing | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external contr | The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays. | accessdata.fda.gov |
| January 20, 2022 | 90225 | Class II | Ongoing | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS T | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay. | accessdata.fda.gov |
| August 15, 2016 | 74982 | Class II | Terminated | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in hum | A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% whe | accessdata.fda.gov |
| July 25, 2016 | 74861 | Class II | Terminated | DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma. | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL. | accessdata.fda.gov |
| October 20, 2014 | 69670 | Class II | Terminated | MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations. | MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32). | accessdata.fda.gov |
| December 2, 2013 | 67011 | Class III | Terminated | MAS Omni Immune Controls | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. | accessdata.fda.gov |
| October 16, 2013 | 66626 | Class II | Terminated | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific T | Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received. | accessdata.fda.gov |
| July 23, 2013 | 65883 | Class II | Terminated | DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay i | Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation. | accessdata.fda.gov |
| May 13, 2013 | 65187 | Class II | Terminated | Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems,, Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of k | It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability. | accessdata.fda.gov |
| August 20, 2012 | 62987 | Class III | Terminated | Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Ass | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. | accessdata.fda.gov |
| December 14, 2011 | 60756 | Not yet classified | Terminated | ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, L | Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges. | accessdata.fda.gov |
| November 11, 2011 | 60503 | Not yet classified | Terminated | Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064..Tobramycin is a commonly used anti | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. | accessdata.fda.gov |
| June 8, 2011 | 60233 | Not yet classified | Terminated | Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage: The Multigent Vancomycin calibrators are intended for use in the calibra | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. | accessdata.fda.gov |
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Updated October 15, 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.