Qiagen recalls AmniSure ROM Test with catalog numbers FMRT-1-25 and FMRT-1-25-CA due to potential control line not appearing on test strips. This may affect pregnant women using the test for amniotic fluid detection.
Potential for control line not appearing on the test strip
Qiagen is recalling AmniSure ROM Test kits with specific catalog numbers because the test strip might not show a control line. This could lead to incorrect results when checking for amniotic fluid during pregnancy.
The test may not show a control line, which is needed to confirm the test worked properly. Without this, the result could be inaccurate, potentially leading to incorrect conclusions about amniotic fluid.
Pregnant women who use the AmniSure ROM Test to check for amniotic fluid in vaginal discharge. Those with the specific catalog numbers and lot numbers listed are most at risk.
Check for catalog numbers FMRT-1-25 or FMRT-1-25-CA on the product label. Also look for lot numbers 557016546, 557016547, 5600115 (expiring 7/28/2020) or 557016409 (expiring 7/28/2020).
Look for catalog numbers FMRT-1-25 or FMRT-1-25-CA and lot numbers listed in the recall notice.
It's a rapid test for detecting amniotic fluid in vaginal discharge during pregnancy.
Check for catalog numbers FMRT-1-25 or FMRT-1-25-CA and lot numbers 557016546, 557016547, 5600115 or 557016409.
The recall does not provide a remedy; the product is being recalled due to potential inaccurate results.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2577-2018 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2577-2018 from Qiagen. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
