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Class 2 Device Recall VITROS 250/350 Mixing Cup Array |
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Date Initiated by Firm |
October 10, 2013 |
Date Posted |
February 10, 2014 |
Recall Status1 |
Terminated 3 on May 18, 2018 |
Recall Number |
Z-0968-2014 |
Recall Event ID |
66498 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JRB
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Product |
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems
Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended 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. The VITROS 350 Chemistry System is intended 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.
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Code Information |
1) VITROS 250 (Product Code 8132086; Model # 3332); 2) VITROS 350 (Product Code 6802153; Model # 3330); 3) Mixing Cup Arrays (Product Code 1631779; Model # n/a) |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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Manufacturer Reason for Recall |
Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Ortho Clinical Diagnostics sent an Important Product Correction Notification dated October 10, 2013 to all affected customer. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Confirmation of Receipt form. For questions contact the Customer Technical Services at 1-800-421-3311. |
Quantity in Commerce |
6380 units (each unit contains 48 arrays with 10 microcups) |
Distribution |
Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain |
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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