BD BBL Sensi Disc Aztreonam - 30 ug¿ recall
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
Why was BD BBL Sensi Disc Aztreonam - 30 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. 231640¿ UDI-DI 00382902316404 Lots 1117192 1211613 1243750 1278287 3214945; Catalog No. ¿231641 UDI-DI 30382902316412 Lots 2304491 3093375 3184116 3214945 3261101 3282901 1117192 1211613 1278287 1305148 2004458 2028924 2090502 2244457
- Product
- BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
- 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)