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Stratus CS Acute Care CCRP TestPak
- Starting date:
- March 24, 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-63008
Reason
Siemens has confirmed that some stratus CS acute care CCRP TestPaks, in named lots, may generate slope errors which result in a failed calibration for the hsCRP assay. As a result, patient and quality control results cannot be generated.
Affected products
Stratus CS Acute Care CCRP TestPak
Lot or serial number
- 426130002
- 426214002
Model or catalog number
CCCRP
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES