Ortho-Clinical Diagnostics: Medical Device Recall in 2018 - (Recall #: Z-3280-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VITROS Sodium Slides, Catalog # 837 9034

Product Classification:

Class II

Date Initiated: May 5, 2018

Date Posted: October 10, 2018

Recall Number: Z-3280-2018

Event ID: 80436

Reason for Recall:

Potential for positively biased results

Status: Terminated

Product Quantity:

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

Voluntary or Mandated:

Voluntary: Firm initiated