Single (specified) analyte controls (assayed and unassayed)

FDA product code JJX · Class 1 · 40 devices · 664 reports · 11 devices named in recalls

• CONTOUR® NEXT 7314

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  227 reports
• FastPack® IP SHBG FastPack® IP SHBG 30 Immunoassay

  Qualigen Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  2 recalls0 reports
• CONTOUR® NEXT 7377

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  95 reports
• ARCHITECT 7K62-25

  Abbott Ireland · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  94 reports
• ARCHITECT 08K2812

  Abbott GmbH · Single (specified) analyte controls (assayed and unassayed)
  1 recall12 reports
• CONTOUR® NEXT 9697

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  56 reports
• ARCHITECT 7K65-02

  Abbott Ireland · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  1 recall0 reports
• McKesson 5011

  Mckesson Medical-Surgical Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  1 recall0 reports
• Atellica IM CKMB MCM 10995534

  Siemens Healthcare Diagnostics Inc. · Single (specified) analyte controls (assayed and unassayed)
  1 recall0 reports
• HCG SERUM CONTROL KIT 138

  Sekisui Diagnostics, LLC · Single (specified) analyte controls (assayed and unassayed)
  1 recall0 reports
• ACE Control Set 1667001

  Sentinel Ch. SPA · Single (Specified) Analyte Controls (Assayed And Unassayed)
  1 recall0 reports
• Eurotrol GlucoTrol-AQ 180.013.002

  Eurotrol B.V. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  1 recall0 reports
• VITROS 6800872

  Ortho Clinical Diagnostics · Single (specified) analyte controls (assayed and unassayed)
  1 recall0 reports
• VITROS 6801427

  Ortho Clinical Diagnostics · Single (specified) analyte controls (assayed and unassayed)
  1 recall0 reports
• VITROS 6192257

  Ortho Clinical Diagnostics · Single (specified) analyte controls (assayed and unassayed)
  1 recall0 reports
• TRUEtrack TRUEtrack Blood Glucose Monitoring System

  Trividia Health, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  41 reports
• CONTOUR® NEXT LINK 9632

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  22 reports
• TRUE FOCUS TRUE FOCUS Self Monitoring Blood Glucose Meter

  Trividia Health, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  13 reports
• CONTOUR® NEXT LINK 9740

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  12 reports
• CONTOUR® NEXT LINK 6203

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  10 reports
• Prodigy Voice Blood Glucose Monitoring System 051900

  Prodigy Diabetes Care, LLC · Single (Specified) Analyte Controls (Assayed And Unassayed)
  10 reports
• TRUEtrack TRUEtrack Blood Glucose Meter FREE METER ONLY

  Trividia Health, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  9 reports
• ReliOn™ Premier Classic Meter 784001

  Wal-Mart Stores, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  8 reports
• Medline MPH1560

  Medline Industries, Inc. · Single (specified) analyte controls (assayed and unassayed)
  8 reports
• CONTOUR® NEXT 7379

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  6 reports
• ARCHITECT 4P52-01

  Abbott GmbH · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  4 reports
• ARCHITECT 7K64-35

  Abbott Ireland · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  4 reports
• ARCHITECT 2K91-33

  Abbott GmbH · Single (specified) analyte controls (assayed and unassayed)
  4 reports
• CONTOUR® NEXT 7315

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  4 reports
• Medline MPH6560

  Medline Industries, Inc. · Single (specified) analyte controls (assayed and unassayed)
  4 reports
• TRUE METRIX TRUE METRIX Control Solution Level 1

  Trividia Health, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  3 reports
• ARCHITECT 8D06-31

  Abbott GmbH · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  3 reports
• ROM Plus® Quality Control Kit ROM-QC

  Clinical Innovations, LLC · Single (Specified) Analyte Controls (Assayed And Unassayed)
  3 reports
• Dimension® Flex Reagent Cartridge HB1C 10483822

  Siemens Healthcare Diagnostics Inc. · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  3 reports
• ARCHITECT 8D06-41

  Abbott GmbH · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
  2 reports
• StatStrip 1.0

  Nova Biomedical Corporation · Single (specified) analyte controls (assayed and unassayed)
  2 reports
• ReliOn™ Premier Voice Basic Meter 780001

  Wal-Mart Stores, Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  2 reports
• CONTOUR® NEXT LINK 6207

  Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)
  1 report
• On Call Express Blood Glucose Monitoring System G115-10D

  Acon Laboratories, Inc. · Single (specified) analyte controls (assayed and unassayed)
  1 report
• Elecsys AntiTSHR Immunoassay 4388780160

  Roche Diagnostics GmbH · Single (specified) analyte controls (assayed and unassayed)
  1 report