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STA Staclot Protein S
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MEDICAL DEVICE RECALLMODERATE

STA Staclot Protein S

Diagnostica Stago recalls STA Staclot Protein S reagent over QC drift within its 4-hour stability period.

What to do

Do not use the STA Staclot Protein S reagent. Contact Diagnostica Stago for instructions on returning the affected product and obtaining a replacement.

Recalled
Listed
Updated
Agency
FDA
Firm
Diagnostica Stago, Inc.
Recall ID
99531
Status
ONGOING

Recall at a glance

Quantity recalled
5220 units

Why it was recalled

Diagnostica Stago is recalling STA Staclot Protein S reagent, used for qualitative and quantitative factor deficiency testing, because a positive drift in QC values was identified within the reagent's stated 4-hour onboard stability period.

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 Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test

UDI-DI
3607450007466, 250331, 270331, 273074, 241, 00746, 2027

Timeline

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

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Editorial summary by Recall Canary · summary updated 2026-08-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification