—#205525

Product

BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K850358
Affected lot / code info: Catalog No. 231634 UDI-DI 00382902316343 Lots 1033870 1244758 2026381 2056573 2277488; Catalog No. 231635¿ UDI-DI 30382902316351 Lots 3062288 3158099 3254299 0344489 1033870 1088039 1116107 1148606 1180379 1211608 1244758 1335697 2026381 2028922 2056573 2180451 2277488 2277490

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Domestic distribution nationwide. International distribution worldwide.

Timeline

Recall initiated: 2024-01-08
Posted by FDA: 2024-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205525. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.