Mach 4 Universal HRP Polymer Kit With DAB (2013-11-20)

Starting date:

November 20, 2013

Posting date:

January 6, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-37265

• Reason
• Affected products

Recalled products

1. Mach 4 Universal HRP Polymer Kit With DAB 

Reason

The manufacturer, Biocare Medical, has recently advised of a performance issue with the Betazoid DAB buffer (Catalogue # DS900l, lot 081913) contained within the Mach 4 Universal HRP-Polymer detection kit (Catalogue # BRI4012l, lot 090913). This recall has been initiated due to the staining performance of the kit. The failure is evident when processing control slides as a complete absence of staining by the chromogen. The root cause of this failure is an incorrect buffer was packaged in the kit.

Affected products