—#205531

Product

BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K020842
Affected lot / code info: Catalog No. 232174 UDI-DI 00382902321743 Lots 1301766 1341479 2119610 2147329 2242618 2276113 2333166 3152004 3181140; Catalog No. 232175¿ UDI-DI 30382902321751 Lots 1301766 2276113 2333166 2333175 3152004 3181140 1341479 2119610 2119612 2147329 2242618

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 #205531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.