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

Recall Z-0382-2022 — Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440

U.S. FDA — Device Enforcement · United States · 2021-10-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0382-2022
Date of alert
2021-10-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Clark Laboratories, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05391516744065
Reported risk: Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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