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Emit® 2000 Quinidine Assay

Siemens Healthcare Diagnostics Inc. · Model 10445329 · UDI-DI 00842768023293

LBZ
1
510(k) clearances
3
Adverse events
2
Recalls
7
Facilities

Description

Emit® 2000 Quinidine Assay labeled with the Beckman Coulter® name

Recalls

DateFirmReason
2026-07-13Siemens Healthcare Diagnostics, Inc.Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk o
2026-07-13Siemens Healthcare Diagnostics, Inc.Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk o

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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.