BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures
BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.
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 risk-of-harm product where quality control and accuracy failures in a diagnostic tool could lead to serious treatment errors including inappropriate antibiotic selection and delayed diagnosis. Although no injuries or illnesses have been reported, the potential for diagnostic harm is significant.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Doripenem, a laboratory testing disc used for antibiotic susceptibility testing. The recall affects catalog number 232219 (UDI-DI 30382902322192) with lot numbers 3040749, 3093444, 3163515, and 3296612. A total of 2,363,168 units have been recalled.
The discs may fail to accurately test H. influenzae resistance to doripenem due to quality control and reproducibility failures. These failures could cause inaccurate susceptibility testing results, which may lead to product discard, delayed test results, or adverse diagnostic outcomes such as delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure.
Clinical laboratories and healthcare facilities using these discs are affected. They should contact their supplier regarding the affected lots.
The recalled product
- Product
- BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
- 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. 232219¿ UDI-DI 30382902322192 Lots 3040749 3093444 3163515 3296612
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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