FDA (Devices) recall action 97037
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 4,214 units affected.
Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.
ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.
Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.