Product Wiki · Recalls · Health Canada — Medical Devices

BD BBL Sensi Disc Ampicillin 2 Μg (AM-2) — recall 76548

Health Canada — Medical Devices · Canada · 2024-11-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76548
Date of alert
2024-11-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Microbiology
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: BD identified through potency test, as part of special stability test requests to monitor Ampicillin AM-2, unsatisfactory results of 65% at 18 months. The potency acceptance criteria is 80-140% and product shelf life is 24 months. A retest with control batch and extended sampling confirmed the low potency results. Recall Start Date: November 6, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-bbl-sensi-disc-ampicillin-2

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