VITEK 2 Identification / Antimicrobial Susceptibility Test Cards. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00523-1

Class II

2017-04-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00523-1

Biomérieux have identified a potential issue for specific product lots that is related to the white pouch which contains vitek 2 test cards. the integrity of some of the pouches may be compromised. a compromised test card pouch can impact card reagents due to the entry of moisture. the white pouch is composed of 5 layers of material, 4 of which are clear. all 5 layers must be compromised for a pouch to potentially allow moisture to enter the pouch. based on internal testing, approximately 20% of card pouches exhibited a visual defect, which is a small puncture or tear in the packaging at the "stitch seal". however, 1 in 200 (0.5%) card pouches that passed careful visual inspection failed further integrity tests.The compromised test card pouch integrity could yield false resistance for antibiotics on the ast panel, cause a false negative extended-spectrum beta-lactamase (esbl) test or result in a false positive urea (ure) reaction on id cards.

bioMérieux is advising users to identify impacted lots and visually inspect the test card pouches on both sides for the defect. The defect is a small puncture or tear in the packaging at the "stitch seal". If the defect is observed, destroy the associated test card(s) and contact bioMérieux for credit or replacement. If the defect is not observed, continue testing as per normal procedure, but increase monitoring for potential testing errors, as visual inspection may not identify all affected ID/AST cards. Repeat testing if you observe results potentially indicative of a pouch defect, as detailed in the customer letter. If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used. A look-back of results previously generated with the affected lots is recommended.