BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539
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-1039-2024
- 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. 231536 UDI-DI 00382902315360 Lots 1060689 1116935 1210905 1242939 1306103 1334461 2004540 2025116 2056456 2108378 2146453 2301307 3003869 3062089 3094151 3118079 3152968 3248444 0309595 0343394; Catalog No. 231539¿ UDI-DI 30382902315392 Lots 2339393 3003869 3062089 3094151 3118079 3152968 3214768 3248444 3282335 0309595 0343394 1060689 1116935 1148543 1210905 1242939 1306103 1334461 2004540 2025116 2056456 2108378 2146453 2277321 2301307
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