Recall Z-1949-2019 ยท KHE Reagent, Occult Blood
Helena Laboratories, Corp.
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
| Date | Aug 8, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email. Customers were to dispose of the product. |
| Quantity | 27/250 pouch kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882799 | HELENA COLOCARE Helena Laboratories, Sep 30, 1988 |