Siemens Healthcare Diagnostics, Inc.: ADVIA¿ 120/2120/2120i SETpoint Calibrator

Hazard

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Details from the source

Reason for recall: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Distribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA. Quantity: 2,020 units Lot/code info: Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.

UPC codes

00630414224343

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.