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RapidQC Complete Level 2 (2014-07-03)
- Starting date:
- July 3, 2014
- Posting date:
- July 15, 2014
- 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-40475
Recalled Products
- RapidQC Complete Level 2
Reason
Siemens Healthcare Diagnositcs has confirmed an error in the expected values chart pertaining to the level 2 pH control range for all Siemens blood gas instruments, namely the RAPIDPoint 400/405/500 systems, RAPIDLab 1200 series systems, RAPIDLab 248/348/348ex systems,RAPIDLab 800 series systems and the RAPIDPoint 340/350 systems.
Due to this error, the recovery of pH for RapidQC complete, level 2, lot # 362303, is elevated on all siemens blood gas systems. It is also possible that some instruments may, on occasion, recover pH out of range high. However, the published target ranges for all other analytes are unaffected.
Affected products
A. RapidQC Complete Level 2
Lot or serial number
- 362303
Model or catalog number
- 10309926
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES