FDAClass IIFebruary 14, 2024

BD BBL Sensi Disc Ofloxacin- 5 ug recall

BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿

Why was BD BBL Sensi Disc Ofloxacin- 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. 231672¿ UDI-DI 30382902316726 Lots 1305177 2039254 2180484 2304476

Product
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
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)
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