Recall archive / FDA device enforcement
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-... — FDA record Z-1284-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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 TACROLIMUS CAL F 10015571-3
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Microgenics Corporation
- Quantity
- 615 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1284-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model/Part Number: 10015573 UDI Codes: (01) 0884883 01259 2 (17) 220310 (10) 74175462 (01) 0884883 01259 2 (17) 220512 (10) 74267412 Lot Numbers: 74175462 74267412 Calibrators within the 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 TACROLIMUS CAL F 10015571-3 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, and VA O.U.S.: Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 6, 2022
- Recall initiation date
- Jan 20, 2022
- Center classification date
- Jun 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.