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.

51–75 of 80

  • ModerateFDA (Devices)·Z-1340-2014·2014-04-16

    LumiQuick Dengue IgG/IgM Tests Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling all lots of its Dengue IgG/IgM tests because they were shipped to US locations without required FDA clearance.

    Product
    Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1384-2014·2014-04-16

    LumiQuick Morphine Strip Recalled for Unapproved Distribution in US

    LumiQuick Diagnostics is recalling Morphine Strip (300) products distributed in California, Florida, New Jersey, Texas, and New York because they were shipped to locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Morphine Strip (300); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1404-2014·2014-04-16

    LumiQuick Fentanyl Test Card Recalled for Unauthorized Distribution

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

    Product
    Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1393-2014·2014-04-16

    LumiQuick Ketamine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling all lots of the Ketamine Test Card because they were shipped to US locations without required FDA clearance.

    Product
    Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1362-2014·2014-04-16

    LumiQuick PSA Test Card Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics Inc. is recalling PSA Test Cards (Whole Blood) because they were shipped to US locations without approved FDA applications or clearance.

    Product
    PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1415-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling CK-MB Test Cards shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (serum); 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-1365-2014·2014-04-16

    LumiQuick Recalls Tramadol Test Cards for Unapproved Distribution

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

    Product
    Tramadol Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1382-2014·2014-04-16

    LumiQuick Methamphetamine Strip Recalled for Unapproved Distribution

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

    Product
    Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1416-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood) because they were shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1355-2014·2014-04-16

    LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution

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

    Product
    Syphilis Test Card (Serum); 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-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-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-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-1405-2014·2014-04-16

    LumiQuick Fentanyl Test Cards Recalled for Unapproved Distribution

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

    Product
    Fentanyl Test Card; 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-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-1339-2014·2014-04-16

    LumiQuick Rickettsia Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Rickettsia IgG/IgM Test Cards because they were shipped to locations without required FDA clearance.

    Product
    Rickettsia IgG/IgM Test Card 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-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