Z-0621-2025Class II

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

Name: Z-0621-2025 BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for...
Creator: Becton Dickinson & Co.
Published: 2024-11-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-11-06 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of 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... on 2024-11-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0621-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-06
Posted: 2024-12-05
Recalling firm: Becton Dickinson & Co
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
Product code: JTN Susceptibility Test Discs, Antimicrobial
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
FDA 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 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: [email protected] Product Complaints, Technical Questions Post-Market Quality [email protected] Recall Questions
Quantity in commerce: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0621-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0621-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-05

Product code JTN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)