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)
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled VITROS Chemistry Products BuBc Slides, which are used to quantitatively measure unconjugated and conjugated bilirubin in blood samples. The slides have been distributed worldwide, including throughout the United States and in countries such as Australia, Canada, China, France, Germany, the United Kingdom, and others. The recall affects all current, past, and future lots of the product.
The reason for the recall is that the drug etrombopag can interfere with the accuracy of bilirubin measurements on these slides, as well as on related VITROS TBIL Slides and VITROS XT TBIL-ALKP Slides. The record does not specify what actions affected consumers should take in response to this recall.
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: 80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534 Lot/code info: All Current, Future and Past Lots UDI: 10758750004829, 10758750009398
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.