Bartels Legionella Urinary Antigen- an adjunct to culture for the… — Class II medical device recall Z-0382-2022
Terminated recall by Clark Laboratories, Inc., reported 2021-12-22, distributed in OH, UT. Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
| Recall number | Z-0382-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clark Laboratories, Inc., Jamestown, NY, United States |
| Recall initiated | 2021-10-11 |
| Classified | 2021-12-15 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2023-03-09 |
| Distributed | OH, UT |
| Quantity | 53 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05391516744065 |
| Lot numbers | 056 |
| Expiration dates | 2022-11-28 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0382-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.