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Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena
Recalled July 17, 2019 · FDA recall Z-1949-2019 · Helena Laboratories
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. · FDA Class II
Units
27/250 pouch kits
Sold at
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.
Description
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Product
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Manufacturer(s)
Helena Laboratories, Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →