The Recall Desk

Manufacturer

LumiQuick Diagnostics Inc.

80 recalls in our database name LumiQuick Diagnostics Inc. as the manufacturing or recalling firm.

What the numbers show

Total
80
Critical
0
Severe
0
Most recent
2014-04-16

Of the 80 recalls from LumiQuick Diagnostics Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 80

  • ModerateFDA (Devices)·Z-1403-2014·2014-04-16

    LumiQuick Fentanyl Test Strips Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Fentanyl Test Strips because they were shipped to US locations without approved FDA applications.

    Product
    Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1412-2014·2014-04-16

    LumiQuick Cardiac Panel Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics is recalling Cardiac Panel Test Cards because they were shipped to locations without approved regulatory clearance.

    Product
    Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1353-2014·2014-04-16

    LumiQuick Salmonella Antigen Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Salmonella typhi/paratyphi Antigen Tests because they were shipped to locations without FDA approval.

    Product
    Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1414-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Myoglobin Test Cards because they were shipped to locations without FDA clearance.

    Product
    Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1389-2014·2014-04-16

    LumiQuick PCP Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling PCP Test Cards because they were shipped to US locations without required FDA clearance.

    Product
    PCP Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1385-2014·2014-04-16

    LumiQuick Morphine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Morphine Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1364-2014·2014-04-16

    LumiQuick Saliva Alcohol Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling all lots of its Saliva Alcohol Test (Catalog 74001) because the products were shipped to US locations without approved regulatory clearance.

    Product
    Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1337-2014·2014-04-16

    LumiQuick Syphilis Test Strips Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling all lots of Syphilis Test Strips (Serum) because they were shipped to locations without approved FDA clearance.

    Product
    Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1413-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1367-2014·2014-04-16

    LumiQuick Drugs of Abuse Panel Test Device Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device because it was shipped to locations without required FDA approvals.

    Product
    Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1343-2014·2014-04-16

    LumiQuick Salmonella typhi Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Salmonella typhi Antigen Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1368-2014·2014-04-16

    LumiQuick Amphetamine Strip Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling Amphetamine Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Amphetamine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1358-2014·2014-04-16

    LumiQuick Dengue NS1 Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling all lots of the Dengue NS1 Antigen Test Card because the products were shipped to US locations without approved regulatory clearance.

    Product
    Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1357-2014·2014-04-16

    LumiQuick Malaria Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics Inc. is recalling Malaria pf/pan Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1386-2014·2014-04-16

    LumiQuick Morphine Strips Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling Morphine Strips (2000) because they were shipped to US locations without required FDA clearance.

    Product
    Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1392-2014·2014-04-16

    LumiQuick Ketamine Strip Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling all lots of its Ketamine Strip because the products were shipped to US locations without required FDA clearance.

    Product
    Ketamine Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1381-2014·2014-04-16

    LumiQuick Methadone Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Methadone Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Methadone Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1351-2014·2014-04-16

    LumiQuick Malaria pf Antigen Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to US locations without required FDA regulatory clearance.

    Product
    Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1348-2014·2014-04-16

    LumiQuick H. Pylori Test Cards Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.

    Product
    H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states