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ADVIA CENTAUR FOLATE ASSAY (2015-07-28)
- Starting date:
- July 28, 2015
- Posting date:
- August 11, 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-54628
Affected Products
- ADVIA Centaur CP System - Folate (FOL) Assay
- ADVIA Centaur System - Folate Assay
Reason
Siemens Healthcare Diagnostics has confirmed low red blood cell control recoveries and low results for red blood cell samples when using the ADVIA Centaur Systems Folate Assay with the kit lots of Folate ascorbic acid/ascorbic acid diluent 54942, 56230 and 70673. The issue is limited to the lot of ascorbic acid diluent in these kits.
Affected products
A. ADVIA Centaur CP System - Folate (FOL) Assay
Lot or serial number
- 54942
- 56230
Model or catalog number
- 124975
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
B. ADVIA Centaur System - Folate Assay
Lot or serial number
- 54942
- 56230
Model or catalog number
- 124975
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES