Drug recall
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
FDA recall event 96044 · Class II · Instrumentation Laboratory
Key facts
| Event ID | 96044 |
|---|---|
| Recall numbers | Z-1020-2025 |
| Recalling firm | Instrumentation Laboratory |
| Product type | Devices |
| Products | HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range. |
| Initiation date | Dec 18, 2024 |
| Report date | Feb 5, 2025 |
| 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: