VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Reported: June 18, 2014 Initiated: April 10, 2014 #Z-1735-2014
Product Description
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Reason for Recall
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
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- Domestic - 835 units, Foreign - 921 units
- Distribution
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.. Recalled by Ortho-Clinical Diagnostics. Units affected: Domestic - 835 units, Foreign - 921 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2014. Severity: Moderate. Recall number: Z-1735-2014.
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