BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733and 231274
This recall is currently active, issued February 8, 2024. It was issued by Becton Dickinson & Co..
- Company
- Becton Dickinson & Co.
- Recall Initiated
- January 8, 2024
- Posted
- February 8, 2024
- Recall Number
- Z-1026-2024
- Quantity
- 2,363,168 total units
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Domestic distribution nationwide. International distribution worldwide.
Lot / Code Info
Catalog No. 230733¿¿ UDI-DI 00382902307334 Lots 1020750 1116997 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 2277205 3003821 3129527 3263117 9336993 0080290 0178844 0258758; Catalog No. 231274¿ UDI-DI 30382902312742 Lots 2277205 3003821 3129527 3263117 0057245 0080290 1057453 1116997 1148461 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 9336993
Root Cause
Process control
Action Taken
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