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STRATUS CS ACUTE CARE SYSTEM-D-DIMER (DDMR) Assay (2015-09-08)
- Starting date:
- September 8, 2015
- Posting date:
- September 29, 2015
- 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-55136
Recalled Products
A. STRATUS CS ACUTE CARE SYSTEM-D-DIMER (DDMR) ASSAY
Reason
D-Dimer TestPaks in lot 405110002, may generate calibration errors, which prevent calibration of the analyzer. As a result, patient and quality control results cannot be generated.
Affected products
A. STRATUS CS ACUTE CARE SYSTEM-D-DIMER (DDMR) ASSAY
Lot or serial number
405110002
Model or catalog number
CDDMRE
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Mailstop 514
Newark, Delaware
19714-6101
UNITED STATES