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Advia Centaur System - Calibrators
- Starting date:
- June 13, 2017
- Posting date:
- July 7, 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-63862
Reason
Confirmed a negative bias for Advia Centaur Enhanced Estradiol (EE2) on the Advia Centaur, Advia Centaur XP and Advia Centaur XPT Systems when calibrating with calibrator 30 kit lots ending in 21 (C3021) as compared to calibrator 30 kit lots ending in 20 (C3020).
Affected products
Advia Centaur System - Calibrators
Lot or serial number
00387A21
00388A21
15448A21
16673A21
36243A21
51211A21
Model or catalog number
10379810
10379811
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES