BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653

FDA device recall Z-1017-2024 · posted 2024-02-08 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

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.

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

Root cause

Process control

Status

Open, Classified

Product code

JTN

Quantity affected

2,363,168 total units

Distribution

Domestic distribution nationwide. International distribution worldwide.

Date initiated

2024-01-08

Date posted

2024-02-08

Location

Sparks, MD

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