FDAFDA · Food and drugs·Recall number Z-1011-2024
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
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. 231628 UDI-DI 00382902316282 Lots 2090490 2146520 2210201 2276143 3062095; Catalog No. 231629¿¿ UDI-DI 30382902316290 Lots 3163306 3163307 3163310 3254307 3254309 3271840 3271853 2146520 2146526 2147225 2210201 2224295 2276143 2276144 3003894 3062095 3090649
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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