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Assay, Porphyrin, Spectrophotometry, Lithium

FDA product code NDW · Class 2 · Clinical Toxicology

48
Registered devices
12
Adverse events
7
Recalls
7
510(k) clearances

Devices with this code

NOVA — NOVA BIOMEDICAL CORPORATIONThermo Scientific Infinity™ — Fisher DiagnosticsADVIA Chemistry Lithium_2 (LITH_2) reagents — Siemens Healthcare Diagnostics Inc.NOVA — NOVA BIOMEDICAL CORPORATIONAtellica CH Li — Siemens Healthcare Diagnostics Inc.NOVA — NOVA BIOMEDICAL CORPORATIONLithium Electrode — Roche Diagnostics GmbHThermo Scientific Infinity™ for Olympus Analyzers — Fisher DiagnosticsNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONADVIA® Chemistry LITH Lithium Reagents — Siemens Healthcare Diagnostics Inc.NOVA/STAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONLithium — Roche Diagnostics GmbHNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONAtellica CH Lithium_2 (LITH_2) — Siemens Healthcare Diagnostics Inc.NOVA — NOVA BIOMEDICAL CORPORATIONDimension Vista® Flex® reagent cartridge LITH — Siemens Healthcare Diagnostics Inc.Li 2 — RANDOX LABORATORIES LIMITED

Recent recalls

DateFirmReason
2022-09-19Siemens Healthcare Diagnostics, Inc.Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium p
2022-09-19Siemens Healthcare Diagnostics, Inc.Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium p
2022-02-09Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
2020-06-05Siemens Healthcare Diagnostics, Inc.Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 f
2019-06-28Sentinel CH SpAAdded an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for ca
2019-06-28Sentinel CH SpAAdded an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for ca
2006-05-15Beckman Coulter IncIncorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show

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