Manufacturers

Sun Biomedical Laboratories, Inc.

3 devices in the database

Device Recall VisuaLine Tricyclic Antidepressants
  • Model / Serial
    Sun Biomedical Part 15-2043; Lot Vis-6SP-Dip 08-021-1; Part 15-2046; lot Vis-6SP-Dip 07-270-1; Part 15-2065, lot Vis-8SP-Dip-07-207-2; Part 15-2072, lot Vis-9SP-Dip-07-106-1; Part 15-2080, lot Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2, Vis-10-Dip-07-231-1; Part 15-2083, lot Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-324-1, VIS 10SP-Dip-08-045-3; Part 15-2085, Lot Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-263-1; Part 15-2095, lot Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; and Part 15-2101, lot Vis-6SP Dip-07-326-1.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • Product Description
    VisuaLine Tricyclic Antidepressants: || Six Dip (COC-THC-OPI-MET-BZD-OXD); || Six Dip (COC-THC-OPI-MET-PCP-OXD); || Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); || Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); || Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); || Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); || Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); || Five Dip (COC-THC-OPI-BZD-OXD); and || Six Dip (CPC-THC-OPI-MET-AMP-OXD). || Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Device Recall VisuaLine Propoxyphene;
  • Model / Serial
    Sun Biomedical Part #: 15-2017, lot number: Vis-PPX Dip 07-094-1-85.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • Product Description
    VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
Device Recall VisuaLine Single Dip Oxycodone
  • Model / Serial
    Sun Biomedical Part Numbers: 15-2016; Product lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • Product Description
    VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.