Recall Z-0621-2025 ยท JTN Susceptibility Test Discs, Antimicrobial
Becton Dickinson & Co.
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
| Date | Dec 5, 2024 (initiated Nov 6, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 o |
| Quantity | 13,190 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.