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

Recall Z-0969-2018 — Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

U.S. FDA — Device Enforcement · United States · 2017-08-11 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0969-2018
Date of alert
2017-08-11
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Randox Laboratories
Product category
device
Product type
Devices
Reported risk: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
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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