FDAFDA · Food and drugs·Recall number Z-0382-2022
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
Published December 22, 2021 · Recall initiated: October 11, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Clark Laboratories, Inc.
- Distributor
- OH, UT
- Lot
- Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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