PlainRecalls
FDA Devices Moderate Class II Terminated

VITROS Sodium Slides, Catalog # 837 9034

Reported: October 10, 2018 Initiated: May 5, 2018 #Z-3280-2018

Product Description

VITROS Sodium Slides, Catalog # 837 9034

Reason for Recall

Potential for positively biased results

Details

Distribution
US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands
Location
Rochester, NY

Frequently Asked Questions

What product was recalled?
VITROS Sodium Slides, Catalog # 837 9034. Recalled by Ortho-Clinical Diagnostics.
Why was this product recalled?
Potential for positively biased results
Which agency issued this recall?
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-3280-2018.