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AUTOCHECK 5+ (2017-07-08)
- Starting date:
- July 8, 2017
- Posting date:
- October 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-64738
Affected products
AUTOCHECK 5+
Reason
Radiometer has recently become aware of AUTOCHECK 5+ level 2 ampoules, may give incorrect results for pO2. A defective QC ampoule may for pO2 give a considerable higher result than the expected assigned value of 13.9 - 14.3 kPa (104-107 mmHg).
Affected products
AUTOCHECK 5+
Lot or serial number
R0689
Model or catalog number
S7745
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK