Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 21, 2026
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.
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Diagnostica Stago, Inc. recalled Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended … - a moderate-severity action.
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended … was recalled by Diagnostica Stago, Inc. in January 21, 2026. Reason: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and p…. Check the official notice for the remedy. Verify recall #Z-1084-2026 with the FDA Devices before acting.
The recall
Diagnostica Stago, Inc. issued this moderate-severity FDA Devices recall-Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and p….
- Moderate
- severity level
- 438 units
- affected scope
- Class II
- classification
- January 21, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1084-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1084-2026) was formally reported on January 21, 2026, with the manufacturer initiating the action on December 15, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Diagnostica Stago, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 438 units.
The documented reason for this recall is: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. Distribution data in the federal record shows the product reached: 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, Lebano…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
438 units
Related Recalls
6
3 from same agency
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.
Reason for recall
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1084-2026 |
| Date reported | January 21, 2026 |
| Date initiated | December 15, 2025 |
| Recalling firm | Diagnostica Stago, Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 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 Britain, Italy, Lebanon, Saudi Arabia, Uga… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1084-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Diagnostica Stago, Inc.. Units affected: 438 units.
Why was this product recalled? ▼
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1084-2026.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1084-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 21, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.