Home › Device types › LBZ
Enzyme Immunoassay, Quinidine
FDA product code LBZ · Class 2 · Clinical Toxicology
9
Registered devices
3
Adverse events
2
Recalls
27
510(k) clearances
Devices with this code
Quinidine — Roche Diagnostics GmbHONLINE TDM Quinidine — Roche Diagnostics GmbHSyva® Emit® 2000 Quinidine Calibrators — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESSyva® Emit® 2000 Qunidine Assay — Siemens Healthcare Diagnostics Inc.QMS Quinidine Immunoassay — Microgenics CorporationARCHITECT — ABBOTT LABORATORIESQuinidine — Roche Diagnostics GmbHEmit® 2000 Quinidine Assay — Siemens Healthcare Diagnostics Inc.
Recent 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 measureme |
| 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 measureme |
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