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Health product recall

AU5400 Chemistry Analyzer

Starting date:
May 14, 2012
Posting date:
June 11, 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-26315

Recalled Products

  1. AU5400 Chemistry Analyzer

Reason

Although the device will indicate when the Ion Selective Electorde (ISE) Sample Probe is fully occluded or near fully occluded as a result of a clot, it may not alarm when only partially occluded.

Affected products

A. AU5400 Chemistry Analyzer

Lot or serial number

All Lots

Model or catalog number
  • AU5400
  • AU5421
  • AU5431
Companies
Manufacturer
Beckman Coulter, Inc.