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

Recall Z-0283-2020 — Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferri

U.S. FDA — Device Enforcement · Ireland · 2019-08-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0283-2020
Date of alert: 2019-08-09
Country / jurisdiction: Ireland
Risk level: Class II
Risk type: recall
Brand: Randox Laboratories Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05055273204032

Reported risk: The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

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