Microgenics recalls

2 official recalls and safety alerts involving Microgenics since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Microgenics or the relevant agency.

1. 2025-11-05
2. US
   Drugs & medicalClass II

   Microgenics Corporation recalls Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303,…

   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.

   FDA · DeviceMicrogenics CorporationWorldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI,…Official notice →
3. 2022-07-06
4. US
   Drugs & medicalClass II

   Microgenics Corporation recalls QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL…

   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.

   FDA · DeviceMicrogenics CorporationU.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC,…Official notice →