ColoCARE — Class II medical device recall Z-1950-2019
Ongoing recall by Helena Laboratories, Corp., reported 2019-07-17, distributed in AK, AR, AZ, CA, CO, CT, FL, GA…. The positive control on some tests of the lots did not appropriately react within the specified timeframe to v
| Recall number | Z-1950-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2018-08-08 |
| Classified | 2019-07-05 |
| Reported by FDA | 2019-07-17 |
| Distributed | 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 |
| Lot numbers | 1-17-551039, 2-17-551039, 2-17-5651, 3-17-5651 |
| Model numbers | 5651 |
| Expiration dates | 2018-08-31, 2018-09-30 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1950-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.