Retiro De Equipo (Recall) de Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical device (IVD)

Recall

RC-2016-RN-01198-1

Class II

2016-09-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01198-1

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.

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.