FDA Device recall Z-1949-2019
ColoCARE, Cat
- FDA Device
- Class II
- ongoing
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of ColoCARE, Cat by Helena Laboratories, citing the positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1949-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-08-08 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Helena Laboratories |
| 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 |
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
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Identifiers
| code_info | 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-…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1949-2019%22
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