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Recall Observatory FDA recall evidence

Device product

VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.

Z-1735-2014

April 10, 2014

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 68271
Status
Terminated
Classification
Class II
Quantity
Domestic - 835 units, Foreign - 921 units
Official record key
device-enforcement:Z-1735-2014

Official wording

Reason: Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Code information: Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912

Distribution pattern: Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected