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U.S. Department of Health and Human Services

Class 2 Device Recall Orhto VITROS XT 7600 Integrated System

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 Class 2 Device Recall Orhto VITROS XT 7600 Integrated Systemsee related information
Date Initiated by FirmJuly 19, 2022
Create DateSeptember 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1676-2022
Recall Event ID 90681
510(K)NumberK182063 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductVITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Code Information UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactSAME
585-453-3000
Manufacturer Reason
for Recall
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. Potential exists for either a positive or negative shift in results reported by the VITROS System.
FDA Determined
Cause 2
Under Investigation by firm
ActionOrtho 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: " 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. " 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 QC results are still outside established ranges following a second system shutdown, contact Ortho Care" Technical Solutions Center for guidance. " Ortho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted. " Post this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved. Ortho is currently investigating this issue; a follow-up communication will be released once our investigation is complete. " Complete the enclosed Confirmation of Receipt no later than July 26, 2022. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce1148 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JJE
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