ABL800 series analyzer with FLEXQ sampler tray (2020-05-06)
- Starting date:
- May 6, 2020
- Posting date:
- May 29, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73205
Last updated: 2020-05-29
Affected Products
ABL800 series analyzer with FLEXQ sampler tray
Reason
Radiometer Medical ApS has received two complaints from the same customer were the customer reports that they have experienced patient data mix up when using ABL800 with FlexQ. Investigation has shown that a software bug caused the incidents. The mix-up will only occur if the analyzer is setup in a specific manner and a specific sequence of events occurs. Please see attached Health Hazard Evaluation for further information.
Affected products
ABL800 series analyzer with FLEXQ sampler tray
Lot or serial number
Software Version 6.19 & below.
Model or catalog number
Not applicable.
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK