Medical Device Recall: BD BBL Cefaclor Antibiotic Susceptibility Test Disc
Becton Dickinson is recalling BD BBL Sensi Disc Cefaclor antibiotic susceptibility test discs due to possible accuracy and quality control failures. Affected discs may produce inaccurate results, risking delayed diagnosis or inappropriate antibiotic selection.
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: FDA Class II medical device with potential to cause serious diagnostic consequences (delayed diagnosis, inappropriate antibiotic selection) but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Becton Dickinson & Co. is recalling the BD BBL Sensi Disc Cefaclor (30 µg), used for semi-quantitative antibiotic susceptibility testing in laboratory settings. Catalog Number 231653. A total of 2,363,168 units were distributed nationwide and internationally.
The manufacturer identified a possibility of reproducibility, accuracy, and quality control failures in antibiotic susceptibility testing for Haemophilus influenzae. Affected discs may not accurately indicate whether bacteria are susceptible to the antibiotic cefaclor.
Laboratories using affected lots (1085898, 1273095, 1273096, 2004485, 2147706, 2333108) should immediately discontinue use. Test results produced with affected discs may require discarding or retesting with alternative methods. Contact Becton Dickinson for replacement products.
Potential consequences of using affected discs include delayed test results, delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic treatment. Healthcare providers and patients concerned about test results performed with these products should consult with their laboratory or physician.
The recalled product
- Product
- BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- qc-failure
- delayed-diagnosis
Distribution
Distributed nationwide across the United States.
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