Class 2 Device Recall VITROS 4600 Chemistry System Software

• Date Initiated by Firm: May 21, 2012
• Date Posted: July 23, 2012
• Recall Status: Terminated on July 05, 2018
• Recall Number: Z-2067-2012
• Recall Event ID: 61910
• 510(K)Number: K031924
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
• Code Information: Version 2.0 & Below
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• Manufacturer Reason for Recall: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
• FDA Determined Cause: Software design
• Action: Ortho Clinical Diagnostics notified its foreign direct account consignees via email on May 21, 2012 and their direct account US consignees were sent an Urgent Distributor Safety Notice on May 22, 2012 via US Postal Service Priority Letter. The recall letter notified the consignees of the situation and that Ortho will replace their remaining inventory of non-expired GENs 14 or 15 for VITROS VALP Reagent only. Until then the consignees can continue using the VITROS VALP Reagent, GENs 14 or 15 until the replacement arrives. And to note that VITROS VANC Reagent, GENs 19 &20 are now expired. --- The letter also requested the consignees to complete and return the enclosed Confirmation of Receipt, no later than May 31, 2012. And to review the quality control beginning with the Calibration date of the VITROS VANC Reagent ( GEN 21 or above) or VITROS VALP (GEN & above) so that the QC results can be verified to be within acceptable ranges. --- For customers using VITROS VALP Reagent GEN 14 or 15, they were to respond as to the quantity of the non-expired GENs 14 and 15 remaining inventory; to load and use only one GEN of VITROS VALP Reagent at a time on the system until the replacement arrives. This notification letter should be posted by each VITROS System using the VITROS VALP Reagent or VITROS VANC Reagent or with the user documentation. And in addition, if these products were distributed then this information should be forwarded as well. For questions regarding this recall call 585-453-4110.
• Quantity in Commerce: 77
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
• 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