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

Recall Z-2207-2019 — Assayed Bovine Multi-Sera Level 1, Model No. AL1027

U.S. FDA — Device Enforcement · United Kingdom · 2019-06-10 · Class III

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2207-2019
Date of alert
2019-06-10
Country / jurisdiction
United Kingdom
Risk level
Class III
Risk type
recall
Brand
Randox Laboratories, Limited
Product category
device
Product type
Devices
Reported risk: The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
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.

Related

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.