FDAFDA · Food and drugs·Recall number Z-1348-2016
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
Published April 13, 2016 · Recall initiated: February 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
- Lot
- Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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