Helena Laboratories recalls ColoCARE diagnostic kits with faulty positive control that may not react properly during testing. 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 in-vitro diagnostic kits that may not properly verify test function due to a positive control issue. This could lead to inaccurate test results if the kit is used without proper verification.
The positive control in some kits fails to react within the required timeframe, which means the test may not be functioning correctly. This could result in inaccurate test results if the kit is used without proper verification.
People using ColoCARE kits for in-vitro diagnostic tests who purchased the affected lots between 2017-2018 are likely affected. Laboratory users and healthcare professionals handling these kits are at higher risk.
Check for kit lot numbers 1-17-551039 (exp. 8/31/2018) or 2-17-551039 (exp. 9/30/2018). The product is packaged in 50 envelopes per box and labeled with Helena Laboratories.
Look for lot numbers 1-17-551039 or 2-17-551039 on the kit packaging.
The positive control in some kits does not react within the specified timeframe, which may cause inaccurate test results.
Check for lot numbers 1-17-551039 (exp. 8/31/2018) or 2-17-551039 (exp. 9/30/2018) on the kit packaging.
The recall does not require stopping use; however, affected kits should be checked for proper function before use.
We’ve drafted a message you can send Helena to request your refund or repair — edit it as you like.
Subject: Recall Z-1950-2019 — Helena Helena Hello, I own a Helena that is covered by recall Z-1950-2019 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.
