Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module 의 리콜

Recall

RC-2017-RN-00853-1

Class I

2017-07-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00853-1

Roche has identified that in very rare cases a sample mismatch may occur in specific immunochemistry modules. this issue can only occur if all 5 conditions below are met simultaneously.1. the immunochemistry module is included in its respective system (not standalone); and2. the “module rack buffer setting” ? 1; and3. one rack (rack a) is undergoing sampling and the following rack (rack b) is waiting for measurement; and4. the gripper (t/v carrier) fails to pick up the last vessel on rack a. as a result, the measurement for the sample in the last vessel which failed to be picked up is cancelled and the warning “tips/cup pick up error” (caution level) is issued; and5. sample position 1 of the following rack (rack b) is empty or has no test order for the immunochemistry module.This issue may be detected by 2 alarms occurring within a few minutes of one another: “tip/cup pick up error” (caution level)“abnormal l2-line movement” (s.Stop level).

Roche Diagnostics is requesting customers follow the detailed instructions given in the Customer Letter and to acknowledge receipt of the communication even if they have no stock which is subject to this recall action.