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Health product recall

AMH Gen II Elisa

Starting date:
November 19, 2012
Posting date:
December 24, 2012
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-25895

Recalled Products

  1. AMH Gen II Elisa

Reason

A number of the Amh Gen II Elisa test kits, lot number 219520 were packaged with the incorrect wash concentrate. These kits were packaged with Wash Concentrate B (Ref DSL-10-9730) instead of Wash Concentrate I (Ref DSL-10-4030).

Affected products

A. AMH Gen II Elisa

Lot or serial number

219520

Model or catalog number

A79765

Companies
Manufacturer
Beckman Coulter Inc.
7075 Financial Drive
Mississauga
L5N 6V8
Ontario
CANADA