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RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Model PIX002 · UDI-DI 00815762020490

JCN Prescription
10
510(k) clearances
2
Adverse events
3
Recalls
9
Facilities

Description

CBC-PIX: 6 x 3.0 mL (2 each Level: Low, Normal, High)

Recalls

DateFirmReason
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.