Lower risk Medical device recall · FDA · Published August 8, 2018

Helena ColoCARE In-Vitro Diagnostic Kits: Positive Control Reaction Issue

Helena Laboratories recalls ColoCARE diagnostic kits with faulty positive control that may not react properly during testing. Affected kits have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1950-2019Medical device Helena ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmHelena Laboratories, Corp.1530 Lindbergh Dr · Beaumont, TX 77707-4131

✎ GovInfoNow plain-language explainer

Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits that may not properly verify test function due to a positive control issue. This could lead to inaccurate test results if the kit is used without proper verification. Read more at govinfonow.com/recall/70152-helena-colocare-in-vitro-diagnostic-kits-positive-control-reaction-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/70152-helena-colocare-in-vitro-diagnostic-kits-positive-control-reaction-issue · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1950-2019

Cite this page

“Helena ColoCARE In-Vitro Diagnostic Kits: Positive Control Reaction Issue.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70152-helena-colocare-in-vitro-diagnostic-kits-positive-control-reaction-issue. Based on FDA recall #Z-1950-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1950-2019%22&limit=1).

Helena Laboratories, Corp. recalled ColoCARE test kits on Aug. 8, 2018, after the FDA announced the positive control did not react appropriately to verify proper function. The firm initiated this voluntary Class II recall.

How to tell if you have it

Brand: Helena
Product: ColoCARE, Cat. No. 5651
Packaging: 50 envelopes/box
Kit lots: 2-17-5651 (exp. 8/31/2018), 3-17-5651 (exp. 9/30/2018)
Pad lot numbers: 1-17-551039 (exp. 8/31/2018), 2-17-551039 (exp. 9/30/2018)
Quantity: 328 kits
Distribution: 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, WY

The hazard

According to the FDA, the positive control on some tests of the affected lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Context

GovInfoNow's records show Helena Laboratories, Corp. has had 8 other recalls since July 21, 2017. Other recent recalls include a Helena Serrated Blade Kit recall on May 2, 2023, and a Helena V8 Immunodisplacement Kit recall on April 6, 2022. Similar product recalls include the Aniara Diagnostica ZYMUTEST HIA IgG Kit recall on April 1, 2026, and Magellan LeadCare II Blood Lead Test Kits recall on March 13, 2026.

How to tell if you have this one

Check for kit lot numbers 1-17-551039 (exp. 8/31/2018) or 2-17-551039 (exp. 9/30/2018). The product is packaged in 50 envelopes per box and labeled with Helena Laboratories.

Brand
Helena
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-1949-2019	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.	27/250 pouch kits
Z-1950-2019	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.	328/50-pouch kits

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Numbers
Look for lot numbers 1-17-551039 or 2-17-551039 on the kit packaging.

Where it went and when

Where it was distributed

Distributed in 34 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, Wyoming.

Recall timeline

FDA published this recall 11 months after the firm started it.

Aug 8, 2018Firm started the recall
Jul 5, 2019FDA classified it Class II
Jul 17, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these kits?

The recall does not require stopping use; however, affected kits should be checked for proper function before use.

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Link to this recall

<a href="https://govinfonow.com/recall/70152-helena-colocare-in-vitro-diagnostic-kits-positive-control-reaction-issue">Helena ColoCARE In-Vitro Diagnostic Kits: Positive Control Reaction Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1950-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1950-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.