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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00853-1
Product Name/Description Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)

cobas e 601 module
Material Number: 04745922001

cobas e 602 module
Material Number: 05990378001

Material Number: 03617505001

Material Number: 04998642001

All software versions

ARTG Number: 173887
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 11/07/2017
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue 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); and
2. The “Module Rack Buffer setting” ? 1; and
3. One rack (Rack A) is undergoing sampling and the following rack (Rack B) is waiting for measurement; and
4. 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; and
5. 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)
Recall Action Recall for Product Correction
Recall Action Instructions 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.

This action has been closed out on 18/10/2019
Contact Information 02 9860 2357 - Roche Diagnostics