---
title: "Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive... — FDA record Z-0382-2022 | Is It on Recall"
description: "Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay"
url: https://isitonrecall.com/recall/fda-device-z-0382-2022-bartels-legionella-urinary-antigen-an-adjunct-to-culture-for-the-presumptive-diagnosis-of-past-or-cu/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnair... — FDA record Z-0382-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 11, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
- **Classification**: Class II
- **Recalling firm**: Clark Laboratories, Inc.
- **Quantity**: 53 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0382-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0382-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

OH, UT

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Ohio](https://isitonrecall.com/state/ohio/)
- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: Dec 22, 2021
- **Recall initiation date**: Oct 11, 2021
- **Center classification date**: Dec 15, 2021
- **Termination date**: Mar 9, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0382-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Clark Laboratories, Inc. records](https://isitonrecall.com/brand/clark-laboratories-inc/)