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    Miss Universe to be aired by streaming service Roku

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    Bob Marley’s grandson dies

    ‘Ellen DeGeneres Show’ DJ Stephen ‘tWitch’ Boss dead by suicide

    ‘Ellen DeGeneres Show’ DJ Stephen ‘tWitch’ Boss dead by suicide

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    Celine Dion diagnosed with incurable disease

    Bob Marley immersive experience in the US next year

    Bob Marley immersive experience in the US next year

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    HSA opens adolescent behavioral health center

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    Health Insurance Commission monitoring Cayman First

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    False: No flight restrictions to Cayman due to COVID

    False: No flight restrictions to Cayman due to COVID

    Long Term Residential Mental Health project not completed

    Long Term Residential Mental Health project not completed

    Dr. Marc Lockhart leaves Mental Health Commission

    Dr. Marc Lockhart leaves Mental Health Commission

    Heart Fund encourages everyone to get CPR training

    Heart Fund encourages everyone to get CPR training

    Health Ministry names incoming Chief Medical Officer

    COVID-19 “XBB Variant” info not issued by Ministry of Health

    Clear masks available for HSA hearing impaired patients

    Clear masks available for HSA hearing impaired patients

    New treatment for acid reflux in the Caribbean

    New treatment for acid reflux in the Caribbean

    Health Ministry names incoming Chief Medical Officer

    One COVID-19 related death reported

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FDA recalls 200,000 Flowflex test kits

Recall does not impact Cayman

by CMR
January 17, 2022
in Health
0
FDA recalls 200,000 Flowflex test kits

Flowflex recalled by FDA

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(CMR) A common rapid at-home COVID test was recalled by the FDA last month over concerns the antigen test hasn't received proper U.S. authorization.

The Food and Drug Administration issued a recall for popular Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) at the end of December stating that the “devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA)”. Despite the FDA's position, the test approved in European and other markets are widely used in the Cayman Islands.

ACOB Laboratories, who manufacture the Flowflex test, said it was aware of the “unauthorized, adulterated and misbranded counterfeit product having the trade name ‘Flowflex SARS-CoV-2 Antigen Rapid Test (Self Testing).’”

The company said it is not importing the test into the U.S. because it is only authorized in Europe and some other markets. The company also recalled the product from the U.S. shortly after the FDA notice.

The recall will impact some 200,000 units in the US market and should not be confused with a similar Flowflex™ COVID-19 Antigen Home Test” which is approved in the U.S.

ACON put out photos of the two. The approved home testing kit is pictured on the right in the white box.

Testing kit recall

Consumers in possession of the unauthorized test are encouraged by the FDA to dispose of the product and if already used to detect a possible COVID infection, seek an additional test from a federally approved provider.

Related posts:

HSA opens adolescent behavioral health center
Health Insurance Commission monitoring Cayman First
False: No flight restrictions to Cayman due to COVID
Long Term Residential Mental Health project not completed
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