[pending] Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qua
Pending LLM rewrite. Source: FDA_DEVICE Z-1084-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
The recalled product
- 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.
- Manufacturer
- Diagnostica Stago, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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