Class 2 Device Recall VITROS 250 Chemistry System Refurbished

• Date Initiated by Firm: April 08, 2019
• Create Date: July 03, 2019
• Recall Status: Terminated on November 12, 2020
• Recall Number: Z-1935-2019
• Recall Event ID: 82784
• 510(K)Number: K922072
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
• Code Information: All lots
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• Manufacturer Reason for Recall: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
• FDA Determined Cause: Device Design
• Action: On 08 April 2019, a customer letter (Ref. CL2019-090) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) to either all customers who were shipped affected VITROS 250 or 350 Systems. This communication provided the following required actions: - As per the VITROS CK Slide Instructions for Use, perform Quality Control (QC) testing daily to help ensure the slides are performing within acceptable limits. - If QC results are outside of the established ranges, discard the cartridge and repeat QC testing using a fresh cartridge of VITROS CK Slides. - If multiple cartridges are loaded on the VITROS 250/350 System, daily QC testing must be performed for each cartridge prior to use. - Consider loading one cartridge of VITROS CK Slides on board your system at a time. - Complete and return the request form via fax to 1-888-557-3759. Foreign affiliates were informed by email on 08 April 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take.
• Quantity in Commerce: 2411 units
• Distribution: US Nationwide Distribution
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE