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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Na Slides

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  Class 2 Device Recall VITROS Chemistry Products Na Slides see related information
Date Initiated by Firm December 20, 2016
Create Date January 31, 2017
Recall Status1 Terminated 3 on June 22, 2018
Recall Number Z-1117-2017
Recall Event ID 76119
510(K)Number K081411  
Product Classification Electrode, ion specific, sodium - Product Code JGS
Product 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.
Code Information Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact
585-453-4224
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JGS and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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