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

Recall Z-0671-2020 — Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the am

U.S. FDA — Device Enforcement · United Kingdom · 2019-02-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0671-2020
Date of alert: 2019-02-19
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: The Binding Site Group, Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05051700018449

Reported risk: Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

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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