Device Recall VITROS Chemistry Products Na Slides 의 리콜

Recall

76119

Class 2

Z-1117-2017

2016-12-20

Terminated

United States

2018-06-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152192

There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using vitros na+ slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the ifu. if quality control (qc) results are within acceptable limits, reported results are acceptable and were not affected by this issue.

Ortho Clinical Diagnostics sent a Urgent Product Correction Notification dated December 20, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who have a VITROS analyzer that can process Na+ Slides to inform them of the potential for biased results on Na+ Slides over the 10 day on-analyzer storage limit for Na+ Slides. Customers were instructed to warm up (equilibrate) all Na Slide cartridges for a minimum of eight hours at room temperature prior to loading them onto the analyzer to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit. Foreign affiliates were informed by email on December 20, 2016, of the issue and instructed to notify their Customers of the issue and the appropriate actions to take. For further questions, please call (585) 453-4224.