# FDA recall Z-0382-2022

> **Clark Laboratories, Inc.** · Class II · device recall initiated 2021-10-11.

## 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

## Reason for recall

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

## Distribution

OH, UT

## Key facts

- **Recall number:** Z-0382-2022
- **Recalling firm:** Clark Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-11
- **Report date:** 2021-12-22
- **Termination date:** 2023-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jamestown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0382-2022

## Citation

> AI Analytics. FDA recall Z-0382-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0382-2022. Source: US FDA. Licensed CC0.

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