VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics Inc. is recalling VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides used to measure total protein concentration in blood serum and plasma on various VITROS Chemistry Systems. The recall affects approximately 491,908 units distributed worldwide, including 223,788 units in the US and 168,120 units in other countries including Canada, Japan, Brazil, Mexico, and others. All current, future, and past lots of these products are included in the recall.
The reason for the recall is eltrombopag interference, which can affect the accuracy of total protein measurements when patients are taking eltrombopag. The source document does not specify a remedy or what affected consumers should do in response to this recall.
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= 223,788 ; OUS:=168,120 Totlal: 491,908 Lot/code info: All Current, Future and Past Lots UDI: 10758750004850
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.