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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: July 5, 2019
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Affected Products

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.

Kit lots 1-17-5650, exp. 8/31/2018, and 2-17-5650, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.

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

Kit lots 2-17-5651, exp. 8/31/2018, and 3-17-5651, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83088
Status: Active
Manufacturer: Helena Laboratories, Corp.
Manufactured In: United States
Units Affected: 2 products (27/250 pouch kits; 328/50-pouch kits)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.