CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
STA Liatest D-Di recalled by Diagnostica Stago
Diagnostica Stago is recalling STA Liatest D-Di, distributed nationwide in the US. The recall was initiated on 12 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0205-2026
- FDA event ID
- 97596
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Sep 2025
- FDA classified
- 16 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Sep 2025 | Recall initiated by company | |
| 16 Oct 2025 | Classified by FDA | +34 days |
| 22 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Product as listed by the FDA
Product: STA Liatest D-Di; REF: 00515;
Where it was distributed
Worldwide distribution- US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Which lots are affected?
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Where was it sold?
Worldwide distribution- US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Diagnostica Stago
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|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
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