BD BBL Sensi Disc Ampicillin (Becton Dickinson) – Potency Decrease (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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. Catalog Number: 231263
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
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).
Products Sold
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).
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used due to BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Recommended Action
Per FDA guidance
BD issued URGENT: Medical Device Product Correction (IDS-24-5142) letter on 11/6/24 to Distributors (included Customer Letter) via e-mail, Letter states reason for recall, health risk and action to take: Actions for Clinical Users: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood by those within your organization. 3. There are no additional recommendations for repeat testing or review of prior results. 4. Share and post this customer letter with users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 5.Complete the attached Customer Response Form and return to your distributor, whether or not you have any of the impacted material. If you require further assistance, please contact: BD Contact Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com Product Complaints, Technical Questions Post-Market Quality BDRC42@bd.com Recall Questions
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026