Recall Z-0220-2023 ยท DKB Calibrators, Drug Mixture
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
| Date | Nov 10, 2022 (initiated Oct 13, 2022) |
| Status | Open, Classified |
| Reason | 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 | 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 th |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.