STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
FDA Recall Z-3047-2026 · Posted 2026-08-28
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Recalling FirmDiagnostica Stago, Inc.
Recall StatusOpen, Classified
Product CodeGGP
Date Initiated2026-07-29
Product Quantity5220 units
Reason for Recall
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Firm Action
Diagnostica Stago issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 7/29/2026 via email. The notice described the issue, risk assessment, and requested the following:
"Actions Required
To prevent potential workflow disruptions associated with the increased recalibration frequency, we request that you:
" Immediately discontinue use of STA-Staclot Protein S, Lot 273074.
" Dispose of any remaining inventory of the affected lot in accordance with your facility's procedures and local regulations.
" Complete, sign, and return the enclosed Acknowledgement Form by email to confirm receipt and understanding of this notification.
Stago will provide a credit for the destroyed kits you indicate on the Acknowledgement Form."
For questions regarding this notice or require assistance, please contact Stago's 24/7 Hotline at 1-800-725-0607.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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