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Enzyme Immunoassay, N-Acetylprocainamide

FDA product code LAN · Class 2 · Clinical Toxicology

9
Registered devices
0
Adverse events
1
Recalls
21
510(k) clearances

Devices with this code

Nacetylprocainamide — Roche Diagnostics GmbHDimension® Flex® reagent cartridge NAPA — Siemens Healthcare Diagnostics Inc.ONLINE TDM N-acetylprocainamide — Roche Diagnostics GmbHDimension Vista® Flex® reagent cartridge NAPA — Siemens Healthcare Diagnostics Inc.Syva® Emit® 2000 N-Acetylprocainamide Calibrators — Siemens Healthcare Diagnostics Inc.Emit® 2000 N-Acetylprocainamide Assay — Siemens Healthcare Diagnostics Inc.Syva® Emit® 2000 N-Acetylprocainamide Assay — Siemens Healthcare Diagnostics Inc.Atellica CH NAPA — Siemens Healthcare Diagnostics Inc.NAcetylProcainamide — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2010-02-05Roche Diagnostics Operations, Inc.The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.