Ortho-Clinical Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-2875-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296

Product Classification:

Class II

Date Initiated: July 13, 2020

Date Posted: September 2, 2020

Recall Number: Z-2875-2020

Event ID: 86070

Reason for Recall:

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

Status: Terminated

Product Quantity: US= 4076 OUS=949

Code Information:

All Current, Future and Past Lots UDI: 10758750031801

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated