![]() ![]() This record will be updated as the status changes.ĥ10(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ The manufacturer has initiated the recall and not all products have been corrected or removed. 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. Samples were tested on the same day on the VITROS XT 7600 and VITROS 5600 Integrated Systems, and the VITROS 4600 and VITROS XT 3400 Chemistry Systems. A total of one hundred thirty six (136) samples were tested, and no samples were modified. Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada 元R 4G5, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.ġ A record in this database is created when a firm initiates a correction or removal action. Our flagship VITROS XT 7600 System brings the full power of digital chemistry to your lab for fast, dependable results and exceptional testing capacity. All Ortho sample aliquots were stored refrigerated at 2-8☌ from the time of draw until tested. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-80. "Ĝomplete the enclosed Confirmation of Receipt no later than July 26, 2022. Ortho is currently investigating this issue a follow-up communication will be released once our investigation is complete. " Post this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted. " Ortho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. If QC results are still outside established ranges following a second system shutdown, contact Ortho Care" Technical Solutions Center for guidance. " If QC results are outside your established ranges, Ortho recommends performing a second system shutdown and re-processing QC fluids for those assays that were outside your established ranges. " If your VITROS XT 3400 and/or VITROS XT 7600 Systems require a system shutdown, routine Quality Control processing for MicroSlide assays must be performed per your laboratory procedure, prior to processing patient samples, to determine if the anomaly has occurred. Ortho CLinical issued Urgent Medical Device Correction letter on 19 July 2022 to consignees who received a VITROS XT3400 or a VITROS XT7600 System notified via (CL2020-176) of the issue and instructed to: Potential exists for either a positive or negative shift in results reported by the VITROS System. Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Systems start with 7600XXXX where XXXX is unique for each analyzer VITROS XT 7600 Integrated System with Version 3.7.2 and below Class 2 Device Recall Orhto VITROS XT 7600 Integrated SystemĪnalyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE ![]()
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