Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products Fs

510(k) K041799

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 · Traditional	NumberK041799	Date25 Aug 2004Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1181-2017 FDA Class III initiated 5 Jan 2017 on shared 510(k) K041799
The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
2 recalls, same reason
- Terminated Z-1804-2014 FDA Class II initiated 12 May 2014 on shared 510(k) K041799
- Terminated Z-1805-2014 FDA Class II initiated 12 May 2014 on shared 510(k) K041799
Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.

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)