FDA recall Z-0382-2022

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 for recall

Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

Distribution

OH, UT

Key facts

Status

Terminated

Initiation date

2021-10-11

Report date

2021-12-22

Termination date

2023-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jamestown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0382-2022