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

Recall Z-1301-2018 — Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using

U.S. FDA — Device Enforcement · United Kingdom · 2018-03-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1301-2018
Date of alert: 2018-03-09
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): 05051700017688

Reported risk: The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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