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FDAOctober 11, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

clark laboratoriesclark

UPCs

05391516744065

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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