Date Initiated by Firm |
March 10, 2023 |
Date Posted |
May 04, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1557-2023 |
Recall Event ID |
92055 |
510(K)Number |
K081543
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802915 |
Code Information |
UDI: 10758750007110
Serial Number Range: J56000147- J56003653 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics, Inc. 1001 Us Highway 202 Raritan NJ 08869-1424
|
For Additional Information Contact |
SAME 908-218-8776
|
Manufacturer Reason for Recall |
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Ortho Clinical issued Important Product Correction letter on 3/10/23 to customers with VITROS XT7600 & 5600 Integrated Systems (CL2023-061) and instructed:
Until further notice, Ortho recommends loosening and then retightening all caps for MicroTip reagents or diluents immediately prior to loading them onto the system. Per the V-Docs/Maintenance Troubleshooting Guide instructions, Manual MicroTip Reagent Pack Cap Removal, Chapter 6 Troubleshooting, Remove reagent pack caps manually if they become too tight for the MICROTIP PACK OPENER to uncap. The purpose of executing this procedure is to loosen the caps without removing them, and then manually tighten the caps.
For VITROS 5600: J33044 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal.
For VITROS XT7600 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal
" Complete the enclosed Confirmation of Receipt form no later than March 24, 2023.
" Please forward this notification if the affected product was distributed outside of your facility.
" Save this notification with your user documentation or post this notification by each VITROS 5600 or XT 7600 System until root cause investigation is completed.
" If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information
Ortho Care Technical Solutions Center at 1-800-421-3311 |
Quantity in Commerce |
1148 units |
Distribution |
Nationwide including Puerto Rico and Bermuda
Foreign:
Australia
Belgium
Brazil
Canada
Chile
China
Colombia
Denmark
France
Germany
India
Italy
Japan
Mexico
Norway
Portugal
Russia
Singapore
Spain
Sweden
The Netherlands
United Kingdom
|
Total Product Life Cycle |
TPLC Device Report
|
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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