FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1084-2026
- Recalling firm
- Diagnostica Stago, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2025-12-15
- Posted
- 2026-01-14
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
- 510(k) numbers
- ["K003767"]
- PMA numbers
- not on file
- Product code
- LCO
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28