Recall Z-1020-2025 ยท KFF Assay, Heparin
Instrumentation Laboratory
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
| Date | Jan 24, 2025 (initiated Dec 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On December 18, 2024 URGENT MEDICAL DEVICE CORRECTION letters were email to customers. Mandatory Customer Actions Based on the above, please take the following immediate actions: - Check inventory for lots of HemosIL Heparin Calibrators (Part No. 0020300600). See Appendix A for a list of in-date lots with corrected value assignments for the HEP CAL 2 and HEP CAL 3 levels. - Follow the instructions below to update the ACL TOP test parameters (same instructions for all models): - Select Setup from the menu bar and then select Test List from the dropdown menu. - From Test List , double click |
| Quantity | 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026) |
| Distribution | Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iran (Islamic Repub |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213464 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO, Oct 4, 2022 |