BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
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-1012-2024
- 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. 230705 UDI-DI 00382902307051 Lots 1301474 1334111 2025840 2146318 2242344 2276051 2333100 3150355 3234179 ; Catalog No. 231264¿ UDI-DI 30382902312643 Lots 2333100 3030225 3058510 3150355 3234179 3282314 1301474 1334111 2003260 2025840 2146318 2242344 2276051; Catalog No. 231263 UDI-DI 30382902312636 Lots 3010977 3058508 3184064 3234190 1302042 2003517 2146414 2243865 2277199 2339360
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