—#205517

Product

BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K865034
Affected lot / code info: Catalog No. 231640¿ UDI-DI 00382902316404 Lots 1117192 1211613 1243750 1278287 3214945; Catalog No. ¿231641 UDI-DI 30382902316412 Lots 2304491 3093375 3184116 3214945 3261101 3282901 1117192 1211613 1278287 1305148 2004458 2028924 2090502 2244457

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 #205517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.