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-1346-2014·2014-04-16

    LumiQuick Adeno/Rota Combo Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics Inc. is recalling Adeno/Rota Combo Test Cards because they were shipped to US locations without required FDA regulatory approvals.

    Product
    Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1397-2014·2014-04-16

    LumiQuick Oxycodone Test Card Recalled for Unapproved Distribution

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

    Product
    Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1390-2014·2014-04-16

    LumiQuick THC Strip Recalled for Unauthorized Distribution in US

    LumiQuick Diagnostics Inc. is recalling all lots of THC Strip (Catalog 74035) because they were shipped to US locations without required FDA clearance.

    Product
    THC Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1370-2014·2014-04-16

    LumiQuick Barbiturate Strip Recalled for Unapproved Distribution

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

    Product
    Barbiturate Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1338-2014·2014-04-16

    LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.

    Product
    Syphilis Test Card Whole Blood(Serum) LumiQuick, 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
  • ModerateFDA (Devices)·Z-1354-2014·2014-04-16

    LumiQuick Salmonella Typhi Test Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without required FDA clearance.

    Product
    Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1410-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to US locations without required FDA clearance.

    Product
    Troponin I test Card (Whole Blood); 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-1378-2014·2014-04-16

    LumiQuick MDMA/Ecstasy Strip Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling MDMA/Ecstasy test strips because they were shipped to locations without required FDA regulatory clearance.

    Product
    MDMA/Ecstasy Strip; 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-1395-2014·2014-04-16

    LumiQuick Buprenorphine Test Cards Recalled for Unapproved Distribution

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

    Product
    Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1373-2014·2014-04-16

    LumiQuick Benzodiazepine Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling Benzodiazepine Test Cards because they were shipped to US locations without approved FDA applications.

    Product
    Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1411-2014·2014-04-16

    LumiQuick Cardiac Panel Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.

    Product
    Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1374-2014·2014-04-16

    LumiQuick Cocaine Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cocaine Strips shipped to US locations without approved FDA applications.

    Product
    Cocaine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1341-2014·2014-04-16

    LumiQuick H. Pylori Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling H. Pylori Antigen Test Cards because they were shipped to locations without required FDA clearance.

    Product
    H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1396-2014·2014-04-16

    LumiQuick Oxycodone Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Oxycodone Strips because they were shipped to US locations without required FDA clearance.

    Product
    Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1409-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to locations without required FDA clearance.

    Product
    Troponin I test Card (serum); 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-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-1400-2014·2014-04-16

    LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution

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

    Product
    Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1352-2014·2014-04-16

    LumiQuick Malaria Pan Antigen Test Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Malaria pan Antigen Test; 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-1380-2014·2014-04-16

    LumiQuick Methadone Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Methadone Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states