Recall Z-1330-2015— 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 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. 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 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
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.