FDA Device recall Z-2185-2021
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
- FDA Device
- Class II
- ongoing
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class II recall of REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859 by Abbott Laboratories, citing 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 pat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2185-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-10 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Reason
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
Identifiers
| code_info | Lot Numbers / Expiration Date 02954UN20 / 29AUG2021 37921UN20 / 01DEC2021 81823UN21 / 16FEB2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2185-2021%22
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