Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
AmniSure ROM Test under the following labels: 1) Catalog Number Recalled by Qiagen Sciences, Inc. Due to Potential for control line not appearing on the...
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, Inc. directly.
Affected Products
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Quantity: 1620 kits
Why Was This Recalled?
Potential for control line not appearing on the test strip
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Qiagen Sciences, Inc.
Qiagen Sciences, Inc. has 2 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report