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Health product recall

Various Dimension Vista Flex Reagent Cartridges (2014-11-12)

Starting date:
November 12, 2014
Posting date:
November 20, 2014
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-42187

Recalled Products

  1. Dimension Vista Flex Theophylline (THEO) reagent cartridges (232661)
  2. Dimension Flex Theophylline (THEO) reagent cartridges (400028)
  3. Dimension Flex Theophylline (THEO) reagent cartridges (544682)
  4. Dimension Flex Theophylline (THEO) reagent cartridges (544814)

Reason

Siemens has confirmed customer complaints of abnormal reaction flags with the affected lots of Dimension Vista Flex Theophylline (THEO) Reagent Cartridges.

Affected products

A. Dimension Vista Flex Theophylline (THEO) reagent cartridges (232661)

Lot or serial number
  • 14148AC
  • 14192AD
Model or catalog number

K4071

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



B. Dimension Flex Theophylline (THEO) reagent cartridges (400028)

Lot or serial number
  • BA5134
  • BA5162
Model or catalog number

DF71

 

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



C. Dimension Flex Theophylline (THEO) reagent cartridges (544682)

Lot or serial number
  • BA5134
  • BA5162
Model or catalog number
  • 10444942
  • DF71
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES



D. Dimension Flex Theophylline (THEO) reagent cartridges (544814)

Lot or serial number
  • BA5134
  • BA5162
Model or catalog number
  • 10444942
  • DF71
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES


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