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-1345-2014·2014-04-16

    LumiQuick Adenovirus Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card because they were shipped to locations without approved FDA applications.

    Product
    Adenovirus Antigen Test Card; 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-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-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-1388-2014·2014-04-16

    LumiQuick PCP Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling PCP Test Strips distributed to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    PCP Test (Strip); 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-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-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-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-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-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-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-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-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-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-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-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-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-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