Recall Z-1329-2015— Lusys Laboratories, Inc.
Class I · Terminated
Class I FDA medical device recall by Lusys Laboratories, Inc., initiated 2015-03-13, terminated 2017-05-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Lusys Laboratories, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-03-13
- Terminated
- 2017-05-31
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.