Z-1117-2017Class II

VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively...

Name: Z-1117-2017 VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively...
Creator: Ortho-Clinical Diagnostics
Published: 2016-12-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-12-20 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma... on 2016-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1117-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-20
Posted: 2017-01-31
Terminated: 2018-06-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JGS Electrode, Ion Specific, Sodium
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1117-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1117-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-31

Product code JGS

K081411Class IIVitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. / cleared 2008-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)