ColoCARE recall
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Why was ColoCARE recalled?
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Helena Laboratories, Corp.
- 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.
- Recall date
- July 17, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)