US regulators recall 10-minute Ebola test

AFP                                                                                April  23, 2015
Miami  - US regulators have issued an international recall for a 10-minute Ebola blood test made by a California-based company, saying it has not been proven to work and could put lives at risk.

"A recall has been issued for the LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits because the FDA has not cleared or approved the kits for use or sale," said the Food and Drug Administration in a statement emailed to reporters on Thursday.

"The results obtained from these test kits have not demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection."

Contacted by AFP, a company representative in San Diego said early trials have shown the test to be 86 percent accurate. The problem with the FDA came down to a labeling error, he said. The equipment had not been properly labeled "for research purposes only."

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