VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2018-RN-00736-1

Class II

2018-06-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00736-1

Ortho clinical diagnostics australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.

Ortho Clinical Diagnostics is advising: For VITROS Na+ Slides, GENs 8 & 13: - Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing. For VITROS Na+ Slides, GENs 14, 16, 17 & 18: - Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing. - It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met: 1. Calibration is successful and Quality Control results are within acceptable limits; and 2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory. If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.