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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