Ortho-Clinical Diagnostics, Inc. 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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.
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic u due to Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VI. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026