BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that 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: Class II medical device recall with no reported illnesses or injuries. The hazard is potential test failure that could lead to delayed diagnosis or inappropriate antibiotic selection, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BD BBL Sensi Disc Tetracycline 30µg is a laboratory diagnostic product used for antibiotic susceptibility testing. Catalog Numbers 230998 and 231344 are affected, with Becton Dickinson & Co. recalling a total of 2,363,168 units distributed both domestically and internationally.
The recall addresses potential reproducibility, accuracy, and/or quality control failures in antibiotic susceptibility testing for H. influenzae. These failures could result in product discard, delayed test results, delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and prolonged treatment.
Multiple affected lot numbers have been identified for each catalog number. The FDA and manufacturer maintain detailed lot information for identification of affected products. Laboratories and healthcare facilities should verify their product inventory against the affected lot numbers.
The recalled product
- Product
- BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
- 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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