BD BBL Sensi Disc Ampicillin 2 Μg (AM-2)
Brand(s)
Last updated
Summary
Product
BD BBL Sensi Disc Ampicillin 2 Μg (AM-2)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
BD BBL Sensi Disc Ampicillin 2 Μg (AM-2) |
3234190 |
231263 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Becton Dickinson And Company (Bd)
7 Loveton Circle, Sparks, Maryland, United States, 21152
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-76548
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