FDA-Device2026-01-21Class IIPROCESSING DEFECT
Diagnostica Stago Asserachrom HPIA lot 271288 recalled for defective test wells
What this means
Diagnostica Stago is recalling lot 271288 of the Asserachrom HPIA test kit, which detects antibodies related to heparin-induced thrombocytopenia (HIT type II). The affected lot may have defective test wells that produce false negative results, meaning the test could fail to detect the condition when it is present.
- Check if you have Asserachrom HPIA lot 271288 (look for lot number on the package)
- Stop using this lot immediately
- Contact Diagnostica Stago or your distributor for instructions on returning or replacing the product
- If tests were run on this lot, consider retesting patients with an alternative method
The agency's original wording
Hazard
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
438 units
Manufactured in
5 Century Dr, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1084-2026More Diagnostica Stago recalls
- FDA-Device2026-09-09Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
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