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

Recall Z-1069-2017 — Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and

U.S. FDA — Device Enforcement · United Kingdom · 2014-09-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1069-2017
Date of alert: 2014-09-11
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: The Binding Site Group, Ltd.
Product category: device
Product type: Devices

Reported risk: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

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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