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

Recall Z-0738-2020 — STA SYSTEM CONROL N + P (ref. 00678)

U.S. FDA — Device Enforcement · United States · 2019-11-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0738-2020
Date of alert
2019-11-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Diagnostica Stago, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
03607450006780
Reported risk: A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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