Ortho-Clinical Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-2874-2020)

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 Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)

Product Classification:

Class II

Date Initiated: July 13, 2020

Date Posted: September 2, 2020

Recall Number: Z-2874-2020

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: 80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534

Code Information:

All Current, Future and Past Lots UDI: 10758750004829, 10758750009398

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