21 results
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45ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
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.
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
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)
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
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
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
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.
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
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.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
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.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
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
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
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.
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
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)
FDA Enforcement
Class I
·Terminated·Lusys Laboratories, Inc.·April 15, 2015
bioMrieux NucliSENS easyMAG Lysis Buffer ref. 280134
FDA Recall
Terminated
·bioMerieux, Inc.·Product code PPM·October 8, 2018
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code JJY·October 12, 2016
VITEK 2 Systems Software Version 9.01 Update Kit.
FDA Recall
Terminated
·bioMerieux, Inc.·Product code LON·November 13, 2018
MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code KYB·July 7, 2008