FDA recall, , Moderate risk
Diagnostica Stago Asserachrom HPIA Kits
Asserachrom HPIA can produce negative results due to a defect affecting every well in the impacted strip.
Summary by Recall Canary from the FDA notice
What happened
Diagnostica Stago, Inc., of Parsippany, New Jersey, recalled Asserachrom HPIA because a potential defect can affect every well in the impacted strip and produce negative results. The kit is intended for the qualitative detection in plasma or serum of anti-heparin-platelet factor 4 (PF4) antibodies generated during type II heparin-induced thrombocytopenia (HIT type II) by ELISA. The company began the recall on December 15, 2025, and the FDA added it to its Enforcement Report on January 14, 2026.
The product was distributed worldwide, including in the United States in Alabama, California, Florida, Georgia, Hawaii, Iowa, Massachusetts, Michigan, New Jersey, Nevada, New York, Ohio, Tennessee and Wisconsin, and in Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia and Uganda. The recall involved 438 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, lot code and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Asserachrom HPIA
- Model number
- 00615
- UDI-DI
- 03607450006155
- Lot code
- 271288
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Alabama, California, Florida, Georgia, Hawaii, Iowa, Massachusetts, Michigan, New Jersey, Nevada, New York, Ohio, Tennessee, Wisconsin and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.
- Company
- Diagnostica Stago, Inc.Parsippany, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98163
- Recall number
- Z-1084-2026
- Quantity recalled
- 438 units
All recalls from Diagnostica Stago, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
