QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS… — Class II medical device recall Z-1284-2022
Ongoing recall by Microgenics Corporation, reported 2022-07-06, distributed in AL, AZ, CA, DC, FL, IA, ID, IL…. Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quanti
| Recall number | Z-1284-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2022-01-20 |
| Classified | 2022-06-24 |
| Reported by FDA | 2022-07-06 |
| Distributed | AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, VA |
| Countries outside the US | BD, BR, CA, DE, IN, KR, MX, MY, TH |
| Quantity | 615 kits |
| Lot numbers | 74175462, 74267412 |
| Model numbers | 10015573 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1284-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.