FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1117-2017
- Recalling firm
- Ortho-Clinical Diagnostics
- 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.
- Status
- Terminated
- Initiated
- 2016-12-20
- Posted
- not on file
- Terminated
- 2018-06-22
- 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 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
- 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.
- Lot, serial or model codes
- Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
- 510(k) numbers
- ["K081411"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 1000305840
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28