Product Wiki · Recalls · Health Canada — Medical Devices

ANTI-CD30 (BER-H2) MOUSE MONOCLONAL PRIMARY ANTIB (2015-08-05) — recall 53738

Health Canada — Medical Devices · Canada · 2015-09-01 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53738
Date of alert
2015-09-01
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: A slight decrease of the staining intensity and percent positive cells was observed. No cases demonstrating complete negative (false negative results) were observed. The investigation results support that the expiration date for the affected lot numbers should be set to 18 months from the date of manufacture instead of the currently marked 24 months.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/anti-cd30-ber-h2-mouse-monoclo

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