RecallRadar

FDA Device recall Z-2875-2020

VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chem…

On 2020-09-02 the FDA classified a Class II recall of VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chem… by Ortho Clinical Diagnostics, citing etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2875-2020
ClassificationClass II
Statusterminated
Initiated2020-07-13
Published2020-09-02
Last updated2026-09-13 11:55 UTC
CompanyOrtho Clinical Diagnostics
DistributionUS

Product

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

Reason

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

Identifiers

code_infoAll Current, Future and Past Lots UDI: 10758750031801

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2875-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.