BD Bacterial Susceptibility Test Discs Recall for Decreased Potency
Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.
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: FDA Class II recall with documented potency degradation that may cause false diagnostic results. No illnesses or injuries have been reported. This is a risk-of-harm product without demonstrated injury, warranting a High severity score.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Ampicillin 2 μg (AM-2), which are in-vitro diagnostic devices used in laboratory susceptibility testing to determine bacterial resistance to ampicillin.
During potency testing as part of stability monitoring, Becton Dickinson identified that ampicillin potency decreased by 65% after 18 months of storage. This degradation may result in false resistant results during susceptibility testing, potentially causing organisms that are susceptible to ampicillin to be reported as resistant.
Approximately 13,190 units were distributed in the United States (California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Nebraska, and Pennsylvania) and internationally in Canada, Belgium, Singapore, and Malaysia. The affected lots have expiration dates ranging from December 31, 2024 through August 21, 2025.
The recalled product
- Product
- BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens.…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 13,190
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 (5)
- UDi-DI: (01)30382902312636 Lot No. (Exp. Date): 2339360 (12/31/2024)
- 3010977 (01/31/25)
- 3058508 (03/31/2025)
- 3184064 (07/02/2025)
- 3234190 (08/21/2025).
Distribution
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