ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
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.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2019