FDAClass IIFebruary 14, 2024

BD BBL Sensi Disc Rifampin- 5 ug recall

BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿

Why was BD BBL Sensi Disc Rifampin- 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. 231541 UDI-DI 00382902315414 Lots 1278110 1334479 2004554 2025125 2056466 2242510 3214931; Catalog No. 231544¿ UDI-DI 30382902315446 Lots 1116055 1211489 2339407 3030278 3158059 3214931 0343413 1032232 1088790 1148547 1278110 1334479 2004554 2025125 2056466 2090443 2242510

Product
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
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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