FDA (Devices) recall action 70668

Lusys Laboratories, Inc. recalled 8 products on 2015-04-15

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2015-04-15
Critical: 0
Units: 2,275

Why these products were recalled

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

LowFDA (Devices)··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
Distribution
1 state
HighFDA (Devices)··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
Distribution
1 state
ModerateFDA (Devices)··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
Distribution
1 state
SevereFDA (Devices)··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
Distribution
1 state
ModerateFDA (Devices)··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
Distribution
1 state
ModerateFDA (Devices)··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
Distribution
1 state
HighFDA (Devices)··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
Distribution
1 state
SevereFDA (Devices)··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
Distribution
1 state