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ONLINE TDM Quinidine
Roche Diagnostics GmbH · Model 08252670190 · UDI-DI 07613336147917
LBZ
Prescription
1
510(k) clearances
3
Adverse events
2
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Siemens 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 |
| 2026-07-13 | Siemens 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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Get your free API keyRead the docsData 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.