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

Lot, batch or date codesREF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;

Quantity recalled12740 units

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: E-Mail
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.

Nationwide

Questions about this recall

Is STA Liatest D-Di recalled?

Yes. Diagnostica Stago recalled STA Liatest D-Di on 12 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0205-2026.

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 21 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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9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
25 Mar 2026Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
11 Mar 2026Device	CLASS II	STA Liatest Free Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
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