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ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS (2017-10-02)
- Starting date:
- October 2, 2017
- Posting date:
- October 27, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64964
Affected products
ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS
Reason
According to the complaint, sample measurement is done using FleXQ and the registration receipt barcode is created automatically, and customer can see a patient's data directly on the analyzer using the registration receipt barcode. In this case, when the registration receipt barcode was read by the analyzer, the analyzer presented the result from a different patient. The incident could not be reproduced.
Affected products
ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS
Lot or serial number
All lots
Model or catalog number
- 393-800
- 393-801
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK