Drug recall
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current…
FDA recall event 89088 · Class II · Clark Laboratories, Inc.
Key facts
| Event ID | 89088 |
|---|---|
| Recall numbers | Z-0382-2022 |
| Recalling firm | Clark Laboratories, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
| Initiation date | Oct 11, 2021 |
| Report date | Dec 22, 2021 |
| Termination date | Mar 9, 2023 |
| City | Jamestown |
| State | NY |
| Country | United States |
| FEI number | 1318354 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: