ARCHITECT STAT Myoglobin Calibrators — Class II medical device recall Z-0891-2022
Ongoing recall by Abbott Laboratories, reported 2022-04-13, distributed nationwide. This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is p
| Recall number | Z-0891-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2022-03-08 |
| Classified | 2022-04-07 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CY, CZ, DE, DK, FR, GR, HR, IQ, IT, LT, LU, MA, PA, PT, QA, RO, SA, SE, TR, ZA |
| Quantity | 402 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00380740003272 |
Product
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
Reason for recall
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
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-0891-2022. 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.