FDA-Device2019-07-17Class II
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Helena Laboratories, Corp.
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.
Sold states
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.
Affected count
328/50-pouch kits
Manufactured in
1530 Lindbergh Dr, Beaumont, TX, United States
Products
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2019Don't want to check this manually?
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