Class 2 Device Recall VITROS 4600 Chemistry System

• Date Initiated by Firm: April 06, 2015
• Date Posted: June 09, 2015
• Recall Status: Terminated on May 25, 2018
• Recall Number: Z-1742-2015
• Recall Event ID: 70917
• 510(K)Number: K081543
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
• Code Information: Product Code: 6802445 Unique Device Identifier No.: 10758750012343
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• Manufacturer Reason for Recall: Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
• FDA Determined Cause: Software design
• Action: On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1-800-421-3311 anytime..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.
• Quantity in Commerce: 255 units total (131 domestically & 255 internationally)
• Distribution: Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
• 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