Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bartels Legionella Urinary Antigen- an adjunct to culture for the Recalled by Clark Laboratories, Inc. Due to Contamination of the conjugate may cause a pipetting...

Date: October 11, 2021
Company: Clark Laboratories, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Clark Laboratories, Inc. directly.

Affected Products

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

Quantity: 53 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: OH, UT

Affected (2 states)Not affected

About Clark Laboratories, Inc.

Clark Laboratories, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report