Lab testing discs recalled for potential antibiotic susceptibility testing failures
Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to 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 a Class II FDA recall of a laboratory diagnostic device with no reported illnesses or injuries. The hazard is a potential quality control failure in antibiotic susceptibility testing that could lead to clinical harm through delayed diagnosis or inappropriate antibiotic selection, but such harm has not been documented. Per the rubric, risk-of-harm products with no reported injury score at the High level.
Plain-English summary
Becton Dickinson & Co. is recalling Sensi Disc Amoxicillin with Clavulanic Acid testing discs (Catalog Nos. 231628 and 231629), used for antibiotic susceptibility testing in clinical laboratories. Approximately 2.3 million units have been distributed domestically nationwide and internationally worldwide.
There is a possibility of reproducibility, accuracy, and quality control failures in antibiotic susceptibility testing. These failures may cause product discard, delayed test results, or additional adverse diagnostic outcomes.
Potential consequences include delayed patient diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment. Clinical laboratories using these discs should contact Becton Dickinson & Co. for further information and replacement options.
The recalled product
- Product
- Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
- 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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