—#122502

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.

FDA product code: JRB — Micro Mixer
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2013-10-10
Posted by FDA: 2014-02-10
Terminated: 2018-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122502. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.