Home / Recalls / Clark Laboratories, Inc. / Z-0382-2022

Z-0382-2022 Class II Terminated

Recalled by Clark Laboratories, Inc. — Jamestown, NY

Recall Details

Product Type: Devices
Report Date: December 22, 2021
Initiation Date: October 11, 2021
Termination Date: March 9, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 53 units

Product Description

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

Reason for Recall

Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

Distribution Pattern

OH, UT

Code Information

Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065