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Health product recall

ADVIA CHEMISTRY SYSTEMS (2015-06-30)

Starting date:
June 30, 2015
Posting date:
July 21, 2015
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-54308

Affected Products

  1. ADVIA CHEMISTRY SYSTEM
  2. ADVIA 1200 CHEMISTRY SYSTEM

Reason

Change in the concentration of N-Acetylcysteine (NAC) that may cause interference for the ADVIA chemistry systems Acetaminophen assay for the lots listed. This issue applies to the ADVIA 1200, 1800, and 2400 chemistry systems and ADVIA chemistry XPT systems

Affected products

A.ADVIA CHEMISTRY SYSTEM

Lot or serial number
  • 46251
  • 46369
  • 46370
  • 46564
  • 46619
  • 46782
  • 47001
Model or catalog number

7989138

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES

B.ADVIA 1200 CHEMISTRY SYSTEM

Lot or serial number
  • 46251
  • 46369
  • 46370
  • 46564
  • 46619
  • 46782
  • 47001
Model or catalog number

7989138

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES