Class 2 Device Recall Ortho Clinical

• Date Initiated by Firm: October 13, 2022
• Date Posted: November 10, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0220-2023
• Recall Event ID: 91051
• Product Classification: Calibrators, drug mixture - Product Code DKB
• 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
• Code Information: 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.
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 1001 Us Highway 202; Raritan NJ 08869-1424
• For Additional Information Contact: SAME; 908-218-8776
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.