BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures
BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.
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: This is an FDA Class II recall with no reported illnesses or hospitalizations. The hazard—accuracy and quality control failures in antibiotic susceptibility testing—is theoretical and could result in delayed diagnosis or inappropriate antibiotic selection, representing a risk-of-harm situation without confirmed adverse events.
Plain-English summary
BD BBL Sensi Disc Imipenem is a medical device used for in vitro antibiotic susceptibility testing. It consists of paper discs impregnated with imipenem (10 micrograms) and is used to test whether bacteria are resistant or susceptible to this antibiotic. The product is manufactured by Becton Dickinson & Co.
The FDA has identified potential failures in the accuracy, reproducibility, and quality control of these test discs when testing Haemophilus influenzae. These failures could result in incorrect test results.
Incorrect test results could delay diagnosis, lead to the selection of inappropriate antibiotics for treatment, or result in extended and unnecessary antibiotic therapy. Approximately 2.3 million units of the affected product have been distributed domestically nationwide and internationally worldwide.
Laboratories and healthcare facilities using affected lot numbers should stop using the product and contact Becton Dickinson & Co. for guidance on replacement or return instructions. Affected lot numbers are provided in the official FDA recall notice.
The recalled product
- Product
- BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 2,363,168
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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