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

Recall Z-1500-2020 — Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

U.S. FDA — Device Enforcement · United Kingdom · 2019-11-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1500-2020
Date of alert
2019-11-06
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)
05051700018319
Reported risk: It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
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.

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