AQT90 (2020-04-05)
- Starting date:
- April 5, 2020
- Posting date:
- May 1, 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-72937
Last updated: 2020-05-01
Affected Products
AQT90
Reason
Radiometer has received reports of occurrences where the barcode readers also installed in the AQT90 has misinterpreted the contents of a barcode for patient ID or accession number used for e.g. sampler identification. The occurrences relate to barcode types not using a check digit, which have been printed locally. A check digit enables the barcode reader to validate the data read by calculating the checksum, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data
Affected products
AQT90
Lot or serial number
Software V 8.12.380.0 & below.
Model or catalog number
- 393-838
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK