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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 250/350 Mixing Cup Array

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 Class 2 Recall
VITROS 250/350 Mixing Cup Array
see related information
Date Posted February 10, 2014
Recall Status1 Open
Recall Number Z-0968-2014
Recall Event ID 66498
Product Classification Micro Mixer - Product Code JRB
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.
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, New York 14626-5101
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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