Diagnostica Stago recalls Asserachrom HPIA kit model 00615 with lot 271288 due to potential false negative results in heparin-induced thrombocytopenia testing. Affected kits may not detect anti-heparin-platelet factor 4 antibodies correctly.
“Diagnostica Stago Asserachrom HPIA Kit Recall: False Negative Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50443-diagnostica-stago-asserachrom-hpia-kit-recall-false-negative-results-risk. Based on FDA recall #Z-1084-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1084-2026%22&limit=1).
The FDA announced on December 15, 2025, that Diagnostica Stago is recalling Asserachrom HPIA kits due to a potential defect producing negative results. The agency issued recall number Z-1084-2026 for the Class II device.
How to tell if you have it
Brand: Diagnostica Stago
Product: Asserachrom HPIA
Model/Catalog Number: 00615
UPC: 03607450006155
Lot Number: 271288
The hazard
The recall affects Asserachrom HPIA lot 271288, which can produce negative results due to a potential defect. This defect may affect every well in the impacted strip.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since October 25, 2017. Recent brand recalls include the STA Staclot Protein S recall on July 29, 2026, and the STA Liatest D-Di recall on February 5, 2026. Other recent recalls of similar products include the Hologic Aptima HPV Assay Kit recall (February 18, 2026), the Siemens Atellica CH Urine Albumin recall (July 6, 2026), and the Aniara Diagnostica ZYMUTEST HIA IgG Kit recall (April 1, 2026).
How to tell if you have this one
Check the lot number on the kit, which is 271288. The product is labeled as Asserachrom HPIA with model number 00615. It was sold for qualitative detection of HIT type II antibodies.
Brand
Diagnostica Stago
Product
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number 271288 on the Asserachrom HPIA kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Georgia, Hawaii, Iowa, Massachusetts, Michigan, Nevada, New Jersey, New York, Ohio, Tennessee, Wisconsin.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1084-2026 (December 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1084-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.