Z-1084-2026Class II

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative...

Name: Z-1084-2026 Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative...
Creator: Diagnostica Stago, Inc.
Published: 2025-12-15
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2025-12-15 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the... on 2025-12-15. FDA classified it as Class II and gives the reason as "Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1084-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-15
Posted: 2026-01-14
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.
Product code: LCO Platelet Factor 4 Radioimmunoassay
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 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 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.
Product codes and lots: Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1084-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1084-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14

Product code LCO

K003767Class IIAsserachrom Hpia Test KitDiagnostica Stago, Inc. / cleared 2001-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)