FDA Device recall Z-0150-2022
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories
- 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 in vitro diagnostic use by laboratory professionals in clinical laboratories 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-0150-2022 |
| 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 in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0150-2022%22
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