FDA-Device2026-09-09Class IIPROCESSING DEFECT
Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
What this means
Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.
- Check your facility's inventory for STA Staclot Protein S Lot 273074 (Exp 3/31/2027).
- Contact Diagnostica Stago or your supplier for instructions on return or replacement.
- Review any patient results generated with this lot and follow your laboratory's quality protocol.
The agency's original wording
Hazard
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.
Affected count
5220 units
Manufactured in
5 Century Dr, N/A, Parsippany, NJ, United States
Products
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3047-2026Want us to check the next one for you?
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