Clark Laboratories, Inc. recalls Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire'…
- Recall date
- October 11, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0382-2022
- FDA classification
- Class II
- Brand / firm
- Clark Laboratories, Inc.
- Sold / distributed
- OH, UT
Why it was recalled
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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