Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in pla
FDA device recall Z-1084-2026 · posted 2026-01-14 · Open, Classified
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LCO
- Quantity affected
- 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 Bri
- Date initiated
- 2025-12-15
- Date posted
- 2026-01-14
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASSERACHROM HPIA TEST KIT (K003767) | Diagnostica Stago, Inc. | 2001-02-12 |