Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2

510(k) K081411

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK081411	Date30 Jun 2008Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0992-2019 FDA Class II initiated 22 Jan 2019
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
- Terminated Z-1117-2017 FDA Class II initiated 20 Dec 2016
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.
2 recalls, same reason
- Terminated Z-1088-2014 FDA Class II initiated 17 Oct 2013 on shared 510(k) K081411
- Terminated Z-1087-2014 FDA Class II initiated 17 Oct 2013
Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K081411
FDA Product Code: JGS
Models / Variants: Vitros Chemistry Product Na+ Slides
Vitros Chemistry Products Calibrator Kit 2