ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Company
- Helena Laboratories, Corp.
- Recall Initiated
- August 8, 2018
- Recall Number
- Z-1949-2019
- Quantity
- 27/250 pouch kits
- Firm Location
- 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.
Lot / 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 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email. Customers were to dispose of the product.
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