BD BBL Ertapenem Susceptibility Test Discs Recalled for Accuracy Failures
BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, delayed diagnosis, or inappropriate antibiotic 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 medical device recall with no reported illnesses or injuries. The hazard is testing accuracy and reproducibility failure that creates risk of diagnostic error and inappropriate antibiotic selection, meeting the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
BD BBL Sensi Disc Ertapenem 10 μg are in vitro diagnostic discs used for antibiotic susceptibility testing. Becton Dickinson & Co. is recalling these products due to a possibility of reproducibility, accuracy, and quality control failures in testing for Haemophilus influenzae.
The testing failures may result in product discard, delayed test results, or adverse diagnostic outcomes. Potential consequences include delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment.
The recall affects 2,363,168 total units distributed nationwide in the United States and internationally worldwide. Catalog Numbers 232174 and 232175 are included in this recall, with specific lot numbers documented by the FDA.
The recalled product
- Product
- BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
- 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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