FDAFDA · Food and drugs·Recall number Z-1037-2024
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
Published February 14, 2024 · Recall initiated: January 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Domestic distribution nationwide. International distribution worldwide.
- Lot
- Catalog No. 231691 UDI-DI 00382902316916 Lots 1301719 2026369 2056587 2119595 3003951 3062107 3118199 3275730; Catalog No. 231692¿ UDI-DI 30382902316924 Lots 3003951 3184117 3223408 3275730 1301719 2026369 2056587 2119595 2147716 2244463 3062107 3118199
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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