Helena Laboratories recalls ColoCARE diagnostic kits that may not properly react in tests, risking inaccurate results. Affected kits have specific lot numbers and expiration dates.
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Helena Laboratories is recalling ColoCARE diagnostic kits that may not function correctly due to a positive control issue. This could lead to inaccurate test results if used without proper verification.
The positive control in some tests doesn't react within the expected timeframe, which means the test might not work properly. This could cause inaccurate results if the test is used without verifying it functions correctly.
People using ColoCARE kits for in-vitro diagnostic tests are affected. Those who have the specific lot numbers and expiration dates listed are most at risk.
Check for the kit lot numbers 1-17-5650 or 2-17-5650 with expiration dates 8/31/2018 or 9/30/2018. The product is labeled as 'Helena Laboratories, Corp.' for in-vitro diagnostic use.
Look for lot numbers 1-17-5650 or 2-17-5650 on the packaging with expiration dates 8/31/2018 or 9/30/2018.
The positive control in some tests doesn't react within the specified timeframe, which may cause inaccurate test results.
Check for lot numbers 1-17-5650 or 2-17-5650 with expiration dates 8/31/2018 or 9/30/2018.
The recall record does not specify a remedy, so contact Helena Laboratories for further instructions.
We’ve drafted a message you can send Helena to request your refund or repair — edit it as you like.
Subject: Recall Z-1949-2019 — Helena Helena Hello, I own a Helena that is covered by recall Z-1949-2019 from Helena. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
