FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544
- Recall number
- Z-1038-2024
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544
- Status
- Open, Classified
- Initiated
- 2024-01-08
- Posted
- 2024-02-08
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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
- Quantity
- 2,363,168 total units
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTN
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28