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

Recall Z-0660-2019 — SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

U.S. FDA — Device Enforcement · Ireland · 2018-11-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0660-2019
Date of alert: 2018-11-19
Country / jurisdiction: Ireland
Risk level: Class II
Risk type: recall
Brand: Randox Laboratories Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05055273204049

Reported risk: Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.

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.

Recall Z-0660-2019 — SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

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