The Recall Desk

Manufacturer

Lusys Laboratories, Inc.

11 recalls in our database name Lusys Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
5
Most recent
2022-03-16

Of the 11 recalls from Lusys Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (45%) 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.

1–11 of 11

  • SevereFDA (Devices)·Z-0717-2022·2022-03-16

    Luscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.

    Product
    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0718-2022·2022-03-16

    FDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization

    Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.

    Product
    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2022·2022-03-16

    LuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.

    Product
    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1329-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1331-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1330-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1335-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1328-2015·2015-04-15

    Lusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1332-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1334-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1333-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state