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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00349-1
Product Name/Description Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)

Material Number: 11544373049 (100 tests)

All Lots lower than 29896103

ARTG Numbers:
224003 (Roche Diagnostics Australia - Clinical chemistry biological screening IVDs)
212706 (Roche Diagnostics Australia - Instrument/analyser IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/05/2018
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Roche has changed the performance claims for the Combur10 Test UX when measured on the Urisys 1100 Analyser.
Roche performed internal performance studies, in order to maintain products’ compliance to current regulatory requirements. These studies determined that the limit of detection (LoD) of certain parameters when measured on the Urisys 1100 Analyser varied from the claims stated in the IFU current at the time of testing.
Parameters with changed LoD are: Protein, Nitrite, Ketone bodies, Leukocytes, and Blood: intact erythrocytes.

Values for all other parameters measured by the Combur10 Test UX remain unchanged.
The lower LoD for visual reading remains unchanged for all parameters.

Roche has received no customer complaints worldwide in relation to this issue.
Recall Action Product Defect Correction
Recall Action Instructions Roche is advising users to verify negative results for Protein, Nitrite, Ketone bodies, Leukocytes or Blood (intact erythrocytes), by visual reading, using the colour scale provided on the test strip vial. In case of discrepant values, the visually determined value shall be reported.

This action has been closed out on 30/07/2021
Contact Information 02 9860 2222 - Roche Diagnostics Austalia