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

Recall Z-2557-2019 — Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.

U.S. FDA — Device Enforcement · Ireland · 2019-07-25 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2557-2019
Date of alert
2019-07-25
Country / jurisdiction
Ireland
Risk level
Class III
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Reported risk: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
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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