Clark Laboratories, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0382-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 11, 2021

Date Posted: December 22, 2021

Recall Number: Z-0382-2022

Event ID: 89088

Reason for Recall:

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

Status: Terminated

Product Quantity: 53 units

Code Information:

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

Distribution Pattern:

OH, UT

Voluntary or Mandated:

Voluntary: Firm initiated