BD BBL Sensi Disc Imipenem- 10 ug recall
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
Why was BD BBL Sensi Disc Imipenem- 10 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. 231644 UDI-DI 00382902316442 Lots 1335006 2056580 2091918 2210318 2301385 3062101 3094134 3118125 3214950; Catalog No. 231645¿ UDI-DI 30382902316450 Lots 3062101 3094134 3118125 3214950 3261103 1335006 2056580 2081151 2091918 2091925 2147704 2210318 2210343 2277500 2301385
- Product
- BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
- 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)