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Advia Centaur / XP / XPT
- Starting date:
- March 9, 2017
- Posting date:
- April 13, 2017
- 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-62990
Reason
Potential for the Advia Centaur Syphilis assay to interfere with the Br (Ca 27.29) assay on the Advia Centaur Systems. This interference only occurs when the Syphilis assay immediately precedes the Br assay on the Advia Centaur, Advia Centaur XP or Advia Centaur XPT systems. The Advia Centaur CP system is not impacted. The issue affects all current and future lots of Advia Centaur Systems Br reagents until a solution is implemented.
Affected products
Advia Centaur / XP / XPT
Lot or serial number
- 20739217
- 41765219
- 1472217
- 47408219
- 67429220
- 73596216
- 83525216
- 89376220
Model or catalog number
- 02419937
- 03896216
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES