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ADVIA Centaur system- CA19-9 Assay
- Starting date:
- October 19, 2016
- Posting date:
- December 16, 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-61462
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/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. This observation impacts customers who use the CA 19-9 Assay on both the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT Systems interchangeably when interpreting serial monitoring patients.
Affected products
ADVIA Centaur system- CA19-9 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