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Advia Chemistry Systems (2013-09-06)

Starting date:
September 6, 2013
Posting date:
September 27, 2013
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-35929

Recalled products

  1. Advia Chemistry System - Advia 1650 Analyzer - Class 2
  2. Advia 1200 Chemistry System -Instrument Class 2
  3. Advia Chemistry System - Advia 1800 Analyzer Class 2
  4. Advia Chemistry System - Advia 2400 Analyzer Class 2

Reason

Siemens has confirmed that the affected devices will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. In cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. If a numerical result is generated with a flag, the ratio will be reported without a flag.

Affected products

A.    Advia Chemistry System - Advia 1650 Analyzer - Class 2
 

Lot or serial number

All lots

Model or catalog number
  • 06363413
  • 073-B002-01
  • 10324237
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

B.    Advia 1200 Chemistry System -Instrument Class 2
 

Lot or serial number

All lots

Model or catalog number
  • 02475632
  • 094-A002-01
  • 10309735
  • M094-A002-01
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

C.    Advia Chemistry System - Advia 1800 Analyzer Class 2
 

Lot or serial number

All lots

Model or catalog number
  • 01412173
  • 073-A021-01
  • 10315183
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

D.    Advia Chemistry System - Advia 2400 Analyzer Class 2

Lot or serial number

All lots

Model or catalog number
  • 01714935
  • 073-A011-02
  • 10315769
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES