Asserachrom HPIA recallZ-1084-2026 · Diagnostica Stago, Inc. · initiated Dec 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1084-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 15, 2025
- Posted by the FDA
- Jan 14, 2026
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 438 units
- Product code
- LCO
- FDA submissions
- K003767
- 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, Uganda.
Product description
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.
Code information (models, lots, serial numbers)
Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Asserachrom® HPIA 00615Diagnostica Stago · PLATELET FACTOR 4 RADIOIMMUNOASSAY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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