| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01316-1 |
| Product Name/Description |
Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD)
All Serial Numbers
ARTG Number: 228382 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has identified that the registration receipt received after placing a sampler in the FLEXQ can be associated with a different sampler if the barcode quality on the receipt has been affected. This issue may occur in the following situation:
1. The analyser is setup to use registration receipts providing a barcode to identify the sampler and thereby the patient result;
2. The sampler is placed in the FLEXQ and a registration receipt is printed from the analyser;
3. The quality of the barcode on the receipt is poor due to improper handling/damage or poor print quality;
4.The registration receipt is later scanned on the analyser to print the result and the analyser misinterprets the barcode; and/or
5. In the event that the misinterpreted barcode matches that of a previous registration receipt printed on that analyser, the damaged registration receipt may be associated with the previous sampler. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising users who are testing a sampler in the FLEXQ and printing a registration receipt to verify that the patient results and demographic information match. Radiometer is developing a software upgrade to change the registration receipt barcode to a more robust version to remove the possibility of the barcode being misinterpreted. Radiometer will notify users when the upgrade is available.
This action has been closed out on 12/10/2020 |
| Contact Information |
1800 247 254 - Radiometer Pacific |