Recall Z-1033-2024— Becton Dickinson & Co.

Name: FDA recall Z-1033-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-08

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-01-08. It names one FDA 510(k) clearance: K963845. Product: BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿. Reason: 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2024-01-08
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K963845 — MEROPENEM, 10 MCG, SENSI-DISCBecton Dickinson Microbiology Systems·cleared 1996-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.