VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics Inc. is recalling VITROS XT Chemistry Products ALB-TP Slides used with VITROS XT 3400 equipment to measure total protein concentration in blood samples. The slides can produce inaccurate results when patients are taking the medication eltrombopag, which interferes with the test. The recall affects approximately 11,100 units distributed worldwide, including 9,802 units in the United States and units in 23 other countries.
All current, future, and past lots of the affected product are included in this recall. The recall notice does not specify what consumers or healthcare providers should do regarding the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Reason for recall: Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides Distribution: Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV. Quantity: US=9802; OUS: 1298 Total: 11,100 Lot/code info: All Current, Future and Past Lots UDI: 10758750031771
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.