Recall Z-1117-2017 ยท JGS Electrode, Ion Specific, Sodium
Ortho-Clinical Diagnostics
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
| Date | Dec 20, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 659,957 Total Units (249,570 units domestically & 410,387 units internationally) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081411 | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 Ortho-Clinical Diagnostics, Inc., Jun 30, 2008 |