FDA Device recall Z-0382-2022
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualita…
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualita… by Clark Laboratories, citing contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0382-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-11 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Clark Laboratories |
| Distribution | OH, UT |
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
Identifiers
| code_info | Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0382-2022%22
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