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STA Liatest D-Di Assay Kit
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MEDICAL DEVICE RECALLMODERATE

STA Liatest D-Di Assay Kit

Diagnostica Stago is recalling the STA Liatest D-Di kit due to a positive bias in D-Dimer measurements that may cause inaccurate test results.

What to do

Professional laboratory personnel should immediately stop using the affected assay kits and contact the manufacturer for further instructions regarding replacement or remediation.

Recalled
Listed
Updated
Recall No.
Z-1585-2026
Agency
FDA
Firm
Diagnostica Stago, Inc.
Recall ID
98362
Status
ONGOING

Recall at a glance

Quantity recalled
34000 units (28446 US, 5554 OUS)

Why it was recalled

Diagnostica Stago is recalling the STA Liatest D-Di kit due to a confirmed positive bias in D-Dimer measurements across the entire analytical range. This issue may lead to inaccurate test results when used for the quantitative determination of D-dimer in venous plasma. The affected product is distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

STA Liatest D-DiModel/Catalog number: REF 00515

UDI-DI
03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158, 03607450005158
–

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-14 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification