# FDA recall Z-1949-2019

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2018-08-08.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1949-2019
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-08-08
- **Report date:** 2019-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beaumont, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2019

## Citation

> AI Analytics. FDA recall Z-1949-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1949-2019. Source: US FDA. Licensed CC0.

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