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RAPIDQC COMPLETE LEVEL 3 (2016-04-12)
- Starting date:
- April 12, 2016
- Posting date:
- April 29, 2016
- 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-58144
Affected Products
RAPIDQC COMPLETE LEVEL 3
Reason
Based on field recovery data, Siemens Healthcare Diagnostics has confirmed that the pH parameter may recover low within range or lower than expected with these three lots of level 3 RAPID QC complete product on both the RAPIDPoint and the RAPIDLab blood gas systems.
Affected products
RAPIDQC COMPLETE LEVEL 3
Lot or serial number
363403
363404
363501
Model or catalog number
10309927
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES