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Recall Observatory FDA recall evidence

Device 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.

Z-1329-2015

March 13, 2015

Class I

Product summary

Firm
Lusys Laboratories, Inc.
Event
Event 70668
Status
Terminated
Classification
Class I
Quantity
1,015 units
Official record key
device-enforcement:Z-1329-2015

Official wording

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.

Code information: Lot No. 12012014B

Distribution pattern: Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.