Recall Z-2323-2025 ยท KFF Assay, Heparin
Instrumentation Laboratory
HemosIL LMW Heparin Controls; Part Number: 0020300200;
| Date | Aug 13, 2025 (initiated Feb 3, 2025) |
| Status | Open, Classified |
| Reason | Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays. |
| Root cause | Process control |
| Action | On February 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Requested Customer Actions Please take the following actions: " Follow the instructions in the original Urgent Medical Device Correction letter to update the ACL TOP test parameters with the corrected value assignments for HemosIL Heparin Calibrators (Part No. 0020300600). " For HemosIL UF Heparin Controls (Part No. 0020300300), continue to use the current target values and acceptance ranges as labeled. " For HemosIL LMW Heparin Controls (Part No. 0020300200), use the reassigned target values and acceptance |
| Quantity | 41,824 units |
| Distribution | Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, J |
| FDA record | Open on fda.gov |