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.

1–25 of 80

  • 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-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-1391-2014·2014-04-16

    LumiQuick THC Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling THC Test Cards shipped to US locations without approved FDA applications.

    Product
    THC Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1360-2014·2014-04-16

    LumiQuick Fecal Occult Blood Test Cards Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards because they were shipped to locations without approved FDA applications or clearances.

    Product
    Fecal Occult Blood Test Card; 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-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-1344-2014·2014-04-16

    LumiQuick Rotavirus Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling all lots of its Rotavirus Test Card because they were shipped to US locations without approved FDA clearance.

    Product
    Rotavirus Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1366-2014·2014-04-16

    LumiQuick Recalls Tramadol Strips Shipped Without FDA Clearance

    LumiQuick Diagnostics Inc. is recalling all lots of Tramadol Strips (Catalog 74003) because they were shipped to US locations without approved FDA applications or clearance.

    Product
    Tramadol Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1402-2014·2014-04-16

    LumiQuick Methylphenidate Test Card Recalled for Unapproved Distribution

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

    Product
    Methylphenidate Test Card; 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-1376-2014·2014-04-16

    LumiQuick EDDP Strip Recalled for Unauthorized Distribution

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

    Product
    EDDP Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1375-2014·2014-04-16

    LumiQuick Cocaine Test Card Recalled for Unauthorized Distribution

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

    Product
    Cocaine Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1350-2014·2014-04-16

    LumiQuick Malaria Test Cards Recalled for Lack of FDA Clearance

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

    Product
    Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • 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-1407-2014·2014-04-16

    LumiQuick K2 Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling K2 Test Strips because they were shipped to locations without FDA clearance.

    Product
    K2 (synthetic Marijuana) Test Strip; 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-1387-2014·2014-04-16

    LumiQuick Morphine Test Card Recalled for Unapproved Distribution

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

    Product
    Morphine Test Card (2000); 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-1342-2014·2014-04-16

    LumiQuick H. Pylori Antibody Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards because they were shipped to locations without required FDA regulatory clearances.

    Product
    H. Pylori Antibody Test Card (Whole Blood) 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-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