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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01198-1
Product Name/Description Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical device (IVD)

ChoiceLine 10 test
Material Number: 03504379023

Combur10 Test UX
Material Number: 11544373049

Combur10 Test
Material Number: 04510089056

Combur9 Test
Material Number: 04510054056

All lots affected

ARTG Number: 224003
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/09/2016
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue The Instructions for Use (IFU) contain an error regarding gram-status of bacteria for the nitrite test. In the Limitations or Accuracy section, gram-negative bacteria have been incorrectly referred to as gram-positive. However, the strip performance is not affected, so the product can still be used as specified. If a physician is not aware that a positive nitrite result is indicative of gram-negative bacteria, but follows the incorrect classification within the IFU, an insufficient class of antibiotic may be chosen for the initial treatment of urinary tract infection (UTI). However, the “gram-classification” of bacteria should be common medical knowledge and use of recommended processes for identification of UTI-causing bacteria (such as urine culture methods) will mitigate risk. Nevertheless, a medical risk for patients due to an insufficient antibiotic chosen initially cannot entirely be excluded.
Recall Action Recall for Product Correction
Recall Action Instructions Roche is advising users of the correct wording for the Instructions for Use (IFU). A revised IFU will be provided to users, and additional information provided with each lot of product until the IFU is corrected. This action has been closed-out on 18/05/2017.
Contact Information 02 9860 2357 - Roche Diagnostics Australia