Home / Recalls / Helena Laboratories, Corp. / Z-1950-2019

Z-1950-2019 Class II Ongoing

Recalled by Helena Laboratories, Corp. — Beaumont, TX

Recall Details

Product Type
Devices
Report Date
July 17, 2019
Initiation Date
August 8, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
328/50-pouch kits

Product Description

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.

Distribution Pattern

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.

Code Information

Kit lots 2-17-5651, exp. 8/31/2018, and 3-17-5651, 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.

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