Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2014-RN-01290-1

Class II

2014-12-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01290-1

A mismatch between the sample id and the test result reported will occur if the following specific circumstances occur. 1. a barcode reading error 0-1502 occurs (error #1)2. the operator then selects “enter id” in order to manually assign the sample tube a sample id number3. another error message of any kind occurs (error #2) before the sample id is entered (the “enter id” screen remains open on the instrument)4. when more than 5 minutes elapse after “error #2” occurs, but before the “enter id” screen is closed by the operator, a third error (error #3) occurs which requires a response from the operator5. the operator then closes the “enter id” screen by touching either the “rack pass” or “back” buttons on the touch screenthis will result in a mismatch between for all subsequent sample racks in that run.

Abacus ALS is providing a software update to correct the issue. Until the software update is installed end users are requested to take the following actions: If a user is presented with a 0-1502 error, BAR CODE ERROR (Sample Rack): - select “Pass” (i.e., do not select “Enter ID”), or - do nothing (since the error will be automatically released after more than five minutes). Any sample with a barcode reading error will then not be processed. It may be processed later in the run after the sample rack has been ejected from the sampling area. This action has been closed-out on 04/04/2017.