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

Recall Z-0903-2023 — Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

U.S. FDA — Device Enforcement · Ireland · 2022-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0903-2023
Date of alert
2022-11-22
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273204896
Reported risk: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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