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Recall Observatory FDA recall evidence

Device 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

Z-0621-2025

November 06, 2024

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 95646
Status
Ongoing
Classification
Class II
Quantity
13,190 units
Official record key
device-enforcement:Z-0621-2025

Official wording

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

Code information: 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).

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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