Home / Recalls / Medical Devices
Clark Laboratories, Inc. recalls Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's
Recalled December 22, 2021 · FDA recall Z-0382-2022 · Clark Laboratories
Hazard
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay · FDA Class II
Units
53 units
Sold at
OH, UT
Description
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Product
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
Manufacturer(s)
Clark Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →