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
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. Quantity: 13,190 units 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).
30382902312636
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.