Recall Z-1084-2026 ยท LCO Platelet Factor 4 Radioimmunoassay
Diagnostica Stago, Inc.
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
| Date | Jan 14, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| Reason | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. |
| Root cause | Under Investigation by firm |
| Action | Diagnostica Stago notified consignees of the recall on about 12/15/2025 via email. Consignees were instructed to stop using Lot 271288 and dispose of all remaining product according to local regulations, and complete, sign, and return the attached Acknowledgement Form provided. Additionally, consignees were instructed that if they have distributed the affected lot to any other laboratory, please notify those recipients of this recall and ask them to complete and return an Acknowledgement Form. |
| Quantity | 438 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003767 | ASSERACHROM HPIA TEST KIT Diagnostica Stago, Inc., Feb 12, 2001 |