BD BBL Sensi Disc Levofloxacin- 5 ug recall
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
Why was BD BBL Sensi Disc Levofloxacin- 5 ug recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. 231705 UDI-DI 00382902317050 Lots 1334510 2004644 2091272 2277179 3030830 3094117 3248344; Catalog No. 231706¿ UDI-DI 30382902317068 Lots 2277179 3030830 3094117 3184118 3248344 1334510 2004644 2091272 2213599
- Product
- BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 2,363,168 total units
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)