Health Canada Warns Recalled Pregnancy Tests May Give False Positives

Health Canada is issuing a safety notice and recall for a brand of home pregnancy test because they may show a false positive result. The health agency is recalling Innovacon Inc.’s hCG One Step Pregnancy Tests because they may detect very low hormone levels and give false positive results to women who are not pregnant.
Health Canada Warns Recalled Pregnancy Tests May Give False Positives

Health Canada has issued a recall for Innovacon Inc.’s hCG One Step Pregnancy Tests due to the potential for false positive results. The tests may detect very low hormone levels, including those that can occur during perimenopause, leading to inaccurate readings for non-pregnant individuals. The recall affects specific model numbers and includes an updated package insert to inform users about interpreting results.

  • Health Canada is recalling Innovacon Inc.’s hCG One Step Pregnancy Tests.
  • The tests may provide false positive results by detecting very low hormone levels.
  • This issue includes hormone levels that can occur at or after the onset of perimenopause.
  • Affected products are model number FHC-202 (devices) and FHC-101 (strips).
  • Customers are advised to consider perimenopausal hormone levels when interpreting results.
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