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# Qiagen Sciences Recalls Membrane Rupture Test
- URL: https://www.fdaweb.com/qiagen-sciences-recalls-membrane-rupture-test/
- Published: 2018-08-08T12:00:00.000Z
- Updated: 2026-09-15T00:24:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142064

Qiagen Sciences has recalled the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display. “A lack of a control line may lead to misinterpretation of test results,” a [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm616123.htm?ref=fdaweb.com) says. “The test is designed to display one line (control line) if the result for the presence of amniotic fluid is negative, and two lines (control line and test result line) if the result for the presence of amniotic fluid is positive.” Additionally, it is possible that the display of a test line in the absence of a control line could be misinterpreted as a negative test when it is a positive test, it says. The test is an aid in diagnosing rupture of membranes in pregnant women.