Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01316-1

Class I

2017-10-16

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01316-1

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/or5. 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.

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.