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
This recall is currently active, issued December 5, 2024. It was issued by Becton Dickinson & Co..
- Company
- Becton Dickinson & Co.
- Recall Initiated
- November 6, 2024
- Posted
- December 5, 2024
- Recall Number
- Z-0621-2025
- Quantity
- 13,190 units
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.
Lot / Code Info
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).
Root Cause
Under Investigation by firm
Action Taken
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