Device 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
Z-0382-2022
Product summary
- Event
- Event 89088
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-0382-2022
Official wording
Reason: Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Code information: Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Distribution pattern: OH, UT
Derived failure modes
-
Unknown
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay