Device product

VITROS Sodium Slides, Catalog # 837 9034

Z-3280-2018

May 05, 2018

Class II

Product summary

Firm: Ortho-Clinical Diagnostics
Event: Event 80436
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-3280-2018

Official wording

Reason: Potential for positively biased results

Code information: UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for positively biased results