FDA Device recall Z-0151-2022
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular we…
- FDA Device
- Class II
- ongoing
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular we… by Instrumentation Laboratory, citing labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0151-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-25 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601
Reason
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Identifiers
| code_info | All currently released lots and future lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0151-2022%22
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