Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena L…

Recall date

August 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1950-2019

FDA classification

Class II

Brand / firm

Helena Laboratories, Corp.

Sold / distributed

Distribution was made to AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WY. There was no foreign/military/government distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.