Quick Facts at a Glance
- Recall Date
- December 15, 2025
- Hazard Level
- HIGH
- Brand
- Diagnostica Stago
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Diagnostica Stago
- Product type
- Diagnostic Kit
- Model numbers
- Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The Asserachrom HPIA kit is used for the qualitative detection of anti-heparin-platelet factor 4 antibodies in plasma or serum. It is primarily utilized in diagnosing heparin-induced thrombocytopenia, a serious condition that can occur after heparin treatment.
Why This Is Dangerous
The defect in the Asserachrom HPIA kit affects every well in the impacted strip, leading to potentially false negative results. This can result in undiagnosed cases of heparin-induced thrombocytopenia, posing severe health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients relying on accurate diagnosis of heparin-induced thrombocytopenia. The potential for false negatives raises critical safety concerns.
Practical Guidance
How to identify if yours is affected
- Check the lot number of your Asserachrom HPIA kit.
- Verify if the lot number matches 271288.
- Confirm if you have received the kit from a healthcare provider or retailer.
Where to find product info
The lot number can typically be found on the packaging or the kit itself, often near the barcode or product details.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact your healthcare provider for further assistance.
- Follow up with Diagnostica Stago via email to inquire about your recall status.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Consult your healthcare provider for alternatives if a product is recalled.
- Be aware of the symptoms of heparin-induced thrombocytopenia for timely diagnosis.
Documentation advice
Keep copies of any correspondence regarding the recall, as well as receipts and product details for your records.
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Product Details
The Asserachrom HPIA kit, Model/Catalog Number 00615, is designed for the qualitative detection of anti-heparin-platelet factor 4 antibodies in plasma or serum. It was distributed widely, including to states such as California, New York, and Florida, as well as internationally.
Key Facts
- Model/Catalog Number: 00615
- Distributed worldwide, including U.S. and several countries
- Potential for false negative results
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Safety Guide
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