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Health product recall

ARCHITECT System - Analyzer - Class 2/ (Accessory-Alkaline Wash) (2015-05-13)

Starting date:
May 13, 2015
Posting date:
June 3, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53669

Recalled Products

A. ARCHITECT System - Analyzer - Class 2/ (Accessory-Alkaline Wash)

Reason

Alkaline wash lot number 49059UN14, accessory to the architect analyzer system, is being recalled due to leaking product and/or material received with loose bottle caps that may have leaked during shipment. Alkaline solution is corrosive and the operator can be exposed when the bottle is leaking.

Affected products

A. ARCHITECT System - Analyzer - Class 2/ (Accessory-Alkaline Wash)

Lot or serial number

49059UN14

Model or catalog number
  • 1G06-11
  • 9D31-20
Companies
Manufacturer
Abbott Laboratories Diagnostic Division
100 Abbott Park Road
Abbot Park, Illinois
60064
UNITED STATES