BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious adverse diagnostic outcomes including delayed diagnosis and inappropriate antibiotic selection. Although no illnesses or injuries have been reported, the risk-of-harm nature of the QC failures warrants a High rating.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs (Catalog Nos. 231703 and 231704) used to test bacterial resistance to the antibiotic meropenem. A total of 2,363,168 units are affected, distributed nationwide and internationally.
The discs may have accuracy, reproducibility, and quality control failures that could compromise the validity of test results for Haemophilus influenzae organisms. This could lead to delayed or incorrect diagnostic outcomes.
If test results are invalid or inaccurate, healthcare providers may fail to diagnose infections correctly or may select inappropriate antibiotics for treatment. This could delay proper diagnosis, result in extended antibiotic exposure, or lead to inappropriate treatment decisions.
Healthcare facilities using these discs should contact Becton Dickinson immediately. The company has identified the affected lots and can provide guidance on discontinued use and replacement options. No illnesses or injuries have been reported to date.
The recalled product
- Product
- BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 2,363,168
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog No. 231703 UDI-DI 00382902317036 Lots 2147649 9065664
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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