ADVIA Chemistry System - High Sensitivity C-Reactive Protein(HSCRP) Assay (2019-11-21)
- Starting date:
- November 21, 2019
- Posting date:
- January 6, 2020
- 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-71989
Last updated: 2020-01-07
Affected Products
ADVIA Chemistry System - High Sensitivity C-Reactive Protein(HSCRP) Assay
Reason
Recall due to current assigned values for ADVIA Chemistry HSCRP Calibrator lot 453610 demonstrate a positive bias of approximately 11% for HSCRP patient samples and quality control material when compared to the European reference material ERM da474/IFCC for CRP measurement.
Affected products
ADVIA Chemistry System - High Sensitivity C-Reactive Protein(HSCRP) Assay
Lot or serial number
453610
Model or catalog number
5006455
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES