BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitativ

FDA device recall Z-0621-2025 · posted 2024-12-05 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

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

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JTN

Quantity affected

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.

Date initiated

2024-11-06

Date posted

2024-12-05

Location

Sparks, MD