Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Diagnostica Stago STA N¿oplastine¿ CI Plus Recalled by Diagnostica Stago, Inc. Due to QC values outside of the assigned ranges (prolonged...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.
Affected Products
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
Quantity: 24043 kits
Why Was This Recalled?
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Diagnostica Stago, Inc.
Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report