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FDAAugust 8, 2018device

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

What to do

FDA enforcement status: Ongoing

Brands named

helena laboratorieshelena

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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