Clark Laboratories, Inc. Recall 89088
Description: 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
Clark Laboratories, Inc. Recall 89088 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0382-2022 |
| Event ID | 89088 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | OH, UT |
| Quantity | 53 units |
| Recall Reason | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
| Device Classification | 20211222 |
| Device Code Info | Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065 |
| Center Classification Date | 20211215 |
| Recall Initiation Date | 20211011 |
| Recalling Firm | Clark Laboratories, Inc. |
| Initial Notification | Letter |
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