Becton Dickinson & Co. BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalo due to There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On January 8, 2024, the firm notified customers through URGENT Medical Device Product Correction letters. Users were instructed to cease use of catalog number 291270, and to refrain from conducting AST for H. influenzae with impacted Sensi-Discs. Customers should destroy any units of catalog number 291270 in their inventory. Customers should share and post the recall notification within their facility network and forward to any customers to whom they may have distributed the product. Future lots of affected Sensi-Disc products (excluding catalog number 291270) will be labeled with a sticker notifying customers "This product should not be used for the semi-quantitative in vitro susceptibility testing of Haemophilus influenzae." Identify impacted lot numbers: https://legacy.bd.com/alerts-notices/IDS-23-4851.asp For customer questions: Phone: 1-844-823-5433 Say "Recall when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026