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Class 2 Device Recall VITROS ECi Immunodiagnostic System |
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Date Initiated by Firm |
February 20, 2019 |
Create Date |
May 06, 2019 |
Recall Status1 |
Terminated 3 on September 15, 2021 |
Recall Number |
Z-1293-2019 |
Recall Event ID |
82311 |
510(K)Number |
K962919
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Product Classification |
Fluorometer, for clinical use - Product Code KHO
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Product |
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents |
Code Information |
Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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Manufacturer Reason for Recall |
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
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FDA Determined Cause 2 |
Software design |
Action |
Ortho Clinical Diagnostics (Ortho) issued an "URGENT PRODUCT CORRECTION NOTIFICATION" , a customer letter (Ref. CL2019-052) dated 21 February 2019 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to customers who were shipped affected VITROS¿ Systems/or whose VITROS System has a luminometer parts replacement. The customers were notified of the issue and instructed to notify Ortho upon experiencing the issue described:
-Avoid performing a shutdown/restart on your systems unless directed by an Ortho representative or prompted by condition code help text.
-If you shutdown/restart and encounter any of the above Luminometer condition codes and are unable to process MicroWell assays, immediately contact the Ortho Care" Technical Solutions Center for service to your system.
-Complete the enclosed Confirmation of Receipt form no later than March 1, 2019 by Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM.
-Please forward this notification if the product was distributed outside of your facility.
Foreign affiliates were informed by email on 21 February 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take.
Questions contact Ortho Care" Technical Solutions Center at 1-800-421-3311. |
Quantity in Commerce |
25 units |
Distribution |
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KHO and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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