Drug recall
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in…
FDA recall event 88627 · Class II · Instrumentation Laboratory
Key facts
| Event ID | 88627 |
|---|---|
| Recall numbers | Z-0149-2022, Z-0150-2022, Z-0151-2022 |
| Recalling firm | Instrumentation Laboratory |
| Product type | Devices |
| Products | 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…, 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…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days |
| Initiation date | Aug 25, 2021 |
| Report date | Oct 27, 2021 |
| City | Bedford |
| State | MA |
| Country | United States |
| FEI number | 1217183 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: