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

Recall Z-0839-2019 — Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

U.S. FDA — Device Enforcement · Ireland · 2018-12-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0839-2019
Date of alert
2018-12-04
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273200904
Reported risk: Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
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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