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

Recall Z-1105-2019 — Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

U.S. FDA — Device Enforcement · Ireland · 2019-02-07 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1105-2019
Date of alert
2019-02-07
Country / jurisdiction
Ireland
Risk level
Class III
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Reported risk: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

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