BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures
BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.
What this means for you
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 risk-of-harm diagnostic device where potential injury (diagnostic errors leading to delayed treatment or inappropriate antibiotic selection) has not yet been reported. The FDA Class II classification and theoretical hazard per the source text support a Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
BD BBL Sensi Disc Cefixime - 5 μg discs (Catalog No. 231664) are being recalled due to potential reproducibility, accuracy, and quality control failures in antibiotic susceptibility testing for H. influenzae. These discs are used in clinical laboratories for semi-quantitative in vitro testing of bacterial susceptibility to cefixime.
Approximately 2,363,168 units were distributed nationwide in the United States and internationally worldwide. Affected lots are: 2004492, 3010077, 3223406, 1305984, and 2091014.
The accuracy failures may cause product discard, delayed test results, or diagnostic errors. Specifically, inaccurate test results could delay diagnosis, lead to selection of inappropriate antibiotics, or result in extended duration of antibiotic exposure and treatment.
Clinical laboratories should discontinue use of affected lots and contact Becton Dickinson & Co. for replacement products. Healthcare providers should review any antibiotic selections made based on tests conducted with affected discs.
The recalled product
- Product
- BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
- 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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