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

Recall Z-0002-2018 — Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analys

U.S. FDA — Device Enforcement · United Kingdom · 2017-08-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0002-2018
Date of alert: 2017-08-23
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): 05051700016421

Reported risk: The high control for the kit is recovering low and may be out of range for assigned values.

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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