Z-0220-2023Class II

VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only

Name: Z-0220-2023 VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2022-10-13
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2022-10-13 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products... on 2022-10-13. FDA classified it as Class II and gives the reason as "Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0220-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-13
Posted: 2022-11-10
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT
Product code: DKB Calibrators, Drug Mixture
Reason for recall: Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics issued Urgent Letter (CL2022-260) to VITROS 250/350 Chemistry System consignees. Letter states reason for recall, health risk and action to take: Upon receiving this communication, load Calibration Diskette DRV 6201 on your VITROS 250/350 Chemistry System and calibrate VITROS PHYT Slides, GEN 22 using VITROS Calibrator Kit 9. Complete the enclosed Confirmation of Receipt form no later than October 21, 2022. Please forward this notification if the affected product was distributed outside of your facility. Save this notification with your user documentation or post this notification by each VITROS 250/350 Chemistry System until Calibration Diskette DRV 6201 has been received and loaded by your facility. If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. If you have further questions, please contact the Ortho Care Technical Solutions Center at 1-800-421-3311
Quantity in commerce: 17,396 Units
Distribution: Worldwide Distribution: US (Nationwide) and Countries (Foreign) including: Australia Bermuda DV04 Bermuda, HM 13 Bermuda, HM08 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden United Kingdom
Product codes and lots: UDI-DI: 10758750005031 Kit Lots/Exp. Date: 0911 24-MAY-2023; 0921 04-OCT-2023; 0942 06-JUN-2024; 0980 26-OCT-2022; 0991 01-MAR-2023 VITROS Chemistry Products PHYT Slides, GEN 22, All lots Calibration Diskette Data Release Versions (DRVs) 6194 through 6200 supporting VITROS Calibrator Kit 9.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0220-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0220-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-10

Product code DKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)