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STA Liatest Free Protein S Kit
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MEDICAL DEVICE RECALLMODERATE

STA Liatest Free Protein S Kit

Diagnostica Stago is recalling the STA Liatest Free Protein S kit due to potential underestimation of protein S levels in normal plasma.

What to do

Contact your laboratory supervisor or healthcare provider if you have concerns regarding recent test results. Discontinue use of the affected kits and contact Diagnostica Stago for further instructions.

Recalled
Listed
Updated
Recall No.
Z-1491-2026
Agency
FDA
Firm
Diagnostica Stago, Inc.
Recall ID
98394
Status
ONGOING

Why it was recalled

Diagnostica Stago is recalling the STA Liatest Free Protein S kit due to the potential for out-of-range results and an underestimation of free protein S levels in normal patient plasma samples. This defect specifically impacts normal-range values, which may lead to inaccurate clinical assessments.

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 Free Protein S Model/Catalog Number (REF): 00516

UDI-DI
03607450005165, 03607450005165, 03607450005165, 03607450005165, 03607450005165

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 →

Other recent recalls from Diagnostica Stago, Inc.

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification