REF 8L92-22 — Class II medical device recall Z-2185-2021
Ongoing recall by Abbott Laboratories, reported 2021-08-11, distributed nationwide. There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater tha
| Recall number | Z-2185-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Irving, TX, United States |
| Recall initiated | 2021-06-10 |
| Classified | 2021-08-02 |
| Reported by FDA | 2021-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AT, AU, BD, BE, BS, CA, CH, CN, CZ, DE, DK, EG, ES, FI, FR, GB, HK, HR, IE, IL, IN, IT, KW, KY, LT, LU, MX, NL, NO, OM, PA, PH, PK, PT, RO, RU, SA, SE, SI, SK, TH, TT, VN |
| Quantity | 1,603 units |
| UPC / GTIN / UDI-DI | 00380740161859 |
| Lot numbers | 01DEC2021, 02954UN20, 16FEB2022, 29AUG2021, 37921UN20, 81823UN21 |
| Model numbers | 8L92-22 |
Product
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Reason for recall
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
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-2185-2021. 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.