CLASS II ONGOING Device recall · Reported 17 Jul 2019 · FDA Enforcement Report
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro recalled
Helena Laboratories is recalling ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro, distributed in 34 states. The recall was initiated on 8 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1950-2019
- FDA event ID
- 83088
- Recalling firm
- Helena Laboratories, Beaumont, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2018
- FDA classified
- 5 Jul 2019
- Reported
- 17 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Aug 2018 | Recall initiated by company | |
| 5 Jul 2019 | Classified by FDA | +331 days |
| 17 Jul 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Where it was distributed
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.
AlaskaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMissouriMississippiMontana
Questions about this recall
Is ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro recalled?
Yes. Helena Laboratories recalled ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro on 8 Aug 2018. The recall is Class II and its status is Ongoing. Recall number Z-1950-2019.
Why was it 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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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