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-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-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-1359-2014·2014-04-16

    LumiQuick Dengue Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling all lots of its Dengue NS1 Ag/IgG/M Ab Duo Test Cards because they were shipped to US locations without the required FDA clearance.

    Product
    Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1361-2014·2014-04-16

    LumiQuick PSA Test Card Recalled for Unapproved Distribution

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

    Product
    PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1377-2014·2014-04-16

    LumiQuick EDDP Test Card Recalled for Unapproved Distribution

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

    Product
    EDDP Test Card; 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-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-1372-2014·2014-04-16

    LumiQuick Benzodiazepine Strips Recalled for Unapproved Distribution

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

    Product
    Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1349-2014·2014-04-16

    LumiQuick Strep A Test Card Recalled for Unauthorized Distribution

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

    Product
    Strep A 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-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-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-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-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-1399-2014·2014-04-16

    LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution

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

    Product
    Propoxyphene Test Strip; 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-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
  • 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-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-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-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-1406-2014·2014-04-16

    LumiQuick Clonazepam Test Card Recalled for Unapproved Distribution

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

    Product
    Clonazepam 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-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