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Health product recall

Active AMH Gen II Elisa

Starting date:
November 27, 2012
Posting date:
January 7, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-16529

Recalled Products

A. Active AMH Gen II Elisa

Reason

Some samples diluted with the AMH Gen II sample diluent prior to running the assay may generate results that are falsely elevated.

Affected products

A. Active AMH Gen II Elisa

Lot or serial number

All Lots

Model or catalog number

A79765

Companies
Manufacturer
Beckman Coulter Inc.