FDA Enforcement
Class II
Terminated
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
Recall: Z-0382-2022
·
Reported December 22, 2021
Enforcement
- Recall Number
- Z-0382-2022
- Event ID
- 89088
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clark Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 22, 2021
- Initiation Date
- October 11, 2021
- Classification Date
- December 15, 2021
- Termination Date
- March 9, 2023
- Address
- 2823 Girts Rd, Jamestown, NY, 14701-9666, United States
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
Reason
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Code Info
Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Distribution
OH, UT
Quantity
53 units