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AVIDA Centaur CP system- CA 19-9 Assay
- Starting date:
- October 19, 2016
- Posting date:
- November 9, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60942
Affected Products
Reason
Siemens Healthcare Diagnostics has observed a system to system bias between the CA 19-9 Assay on the Advia Centaur CP and Advia Centaur XP/Advia Centaur XPT systems with the Advia Centaur CP generating lower results than the Advia Centaur/Advia Centaur XP/Advia Centaur XPT System for patient samples. Siemens is actively pursuing the cause of this issue.
Affected products
AVIDA Centaur CP system- CA 19-9 Assay
Lot or serial number
kits ending in 380
kits ending in 382
kits ending in 384
kits ending in 386
kits ending in 388
kits ending in 390
Model or catalog number
10491244
10491379
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES