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
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry Products TBIL-ALKP Slides used for in vitro diagnostic testing. The recall affects the TBIL test component within these slides due to interference from the drug etrombopag, which can affect test results. The affected products were distributed worldwide, including throughout the United States and in countries including Canada, Australia, the United Kingdom, France, Germany, China, Brazil, Mexico, and others. A total of 4,076 units were distributed in the US and 949 units were distributed outside the US, affecting all current, past, and future lots of this product.
The recall notice does not specify a remedy or recommended course of action for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Reason for recall: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides Distribution: 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. Quantity: US= 4076 OUS=949 Lot/code info: All Current, Future and Past Lots UDI: 10758750031801
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.