Z-3280-2018 Class II Terminated

Recalled by Ortho-Clinical Diagnostics — Rochester, NY

Recall Details

Product Type
Devices
Report Date
October 10, 2018
Initiation Date
May 5, 2018
Termination Date
February 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

VITROS Sodium Slides, Catalog # 837 9034

Reason for Recall

Potential for positively biased results

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

Code Information

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