VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products TBIL Slides (product code 81) used to measure total bilirubin levels in blood samples. The recall affects all current, past, and future lots of these slides due to interference from the drug etrombopag, which can affect the accuracy of test results. The products were distributed worldwide, including throughout the United States and in numerous countries including Canada, Australia, China, France, Germany, the United Kingdom, and others, with approximately 149,370 units distributed in the US and 223,069 units distributed outside the US.
The recall also applies to related VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides affected by the same etrombopag interference issue. The source document does not specify a remedy or corrective action for affected consumers.
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= 149370 OUS=223069 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.