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U.S. Department of Health and Human Services

Class 2 Device Recall ColoCARE

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  Class 2 Device Recall ColoCARE see related information
Date Initiated by Firm August 08, 2018
Create Date July 05, 2019
Recall Status1 Open3, Classified
Recall Number Z-1950-2019
Recall Event ID 83088
510(K)Number K882799  
Product Classification Reagent, occult blood - Product Code KHE
Product ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
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.
Recalling Firm/
Manufacturer		 Helena Laboratories, Corp.
1530 Lindbergh Dr
Beaumont TX 77707-4131
For Additional Information Contact Dr. Jessica Jones Hanka
409-842-3714 Ext. 1177
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 328/50-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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KHE and Original Applicant = HELENA LABORATORIES
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