BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled
BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.
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 medical device recall with no reported adverse events. The hazard is theoretical—potential accuracy failures in diagnostic testing. Per the rubric, theoretical hazards with no reported illnesses or injuries result in a maximum score of 3, but diagnostic test failures affecting antibiotic selection represent a risk-of-harm situation.
Plain-English summary
BD BBL Sensi Disc Rifampin - 5 microgram antibiotic susceptibility test discs have been recalled due to the potential for accuracy and quality control failures. Becton Dickinson & Co. is recalling 2,363,168 units distributed domestically nationwide and internationally.
The FDA has identified a possibility of reproducibility, accuracy, and quality control failures in testing for Haemophilus influenzae using these discs. Such failures could result in incorrect test results, product discard, or delayed testing. These inaccurate results may lead to delayed diagnosis, inappropriate antibiotic selection, or extended duration of antibiotic exposure and treatment.
Laboratories using affected catalog numbers 231541 and 231544 should verify their inventory against the provided lot numbers and contact the manufacturer for guidance on the recalled products.
The recalled product
- Product
- BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
- 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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