Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AmniSure ROM Test Recalled by Qiagen Sciences LLC Due to An image on the associated polybag contains an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qiagen Sciences LLC directly.
Affected Products
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
Quantity: 1654 kit boxes
Why Was This Recalled?
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Qiagen Sciences LLC
Qiagen Sciences LLC has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report