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

Recall Z-2279-2018 — Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

U.S. FDA — Device Enforcement · Ireland · 2018-05-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2279-2018
Date of alert
2018-05-22
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Reported risk: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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