BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy 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 an FDA Class II recall for a risk-of-harm medical device where potential adverse outcomes (delayed diagnosis, improper treatment) have not been reported. The hazard is stated as possible but theoretical, with no documented illnesses or injuries.
Plain-English summary
Becton Dickinson & Co. is recalling approximately 2.3 million BD BBL Sensi Disc Ofloxacin 5 microgram units used for antibiotic susceptibility testing. The affected catalog number is 231672, and the recall includes lots 1305177, 2039254, 2180484, and 2304476. These discs have been distributed domestically nationwide and internationally worldwide.
The discs may have accuracy and quality control failures during susceptibility testing for H. influenzae organisms. This could result in delayed test results, product discard, incorrect test interpretation, delayed diagnosis of infection, selection of inappropriate antibiotics, or extended duration of antibiotic treatment.
Laboratory facilities using these testing discs should verify whether they received any of the affected lots and take appropriate action based on guidance from Becton Dickinson & Co.
The recalled product
- Product
- BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 2,363,168
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog No. 231672¿ UDI-DI 30382902316726 Lots 1305177 2039254 2180484 2304476
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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