Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ColoCARE Recalled by Helena Laboratories, Corp. Due to The positive control on some tests of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Helena Laboratories, Corp. directly.
Affected 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.
Quantity: 328/50-pouch kits
Why Was This 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.
Where Was This Sold?
This product was distributed to 34 states: AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, MT, NE, NV, NY, NC, ND, OH, OK, PA, SD, TN, TX, VA, WA, WY
About Helena Laboratories, Corp.
Helena Laboratories, Corp. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report