Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-2993-2018

U.S. FDA — Device Enforcement · United States · 2018-07-24 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2993-2018
Date of alert: 2018-07-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Diagnostica Stago, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03607450006674

Reported risk: QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related