Class 2 Device Recall Asserachrom HPIA

• Date Initiated by Firm: December 15, 2025
• Date Posted: January 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1084-2026
• Recall Event ID: 98163
• 510(K)Number: K003767
• Product Classification: Platelet factor 4 radioimmunoassay - Product Code LCO
• Product: 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.
• Code Information: Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: Technical Hotline; 800-7250607
• Manufacturer Reason for Recall: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LCO