AmniSure International LLC AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
Brand
AmniSure International LLC
Lot Codes / Batch Numbers
Lot Number/ Exp. Date A7003, 01/2009. A7002, 11/2008, A7001, 10/2008, A6005, 04/2008, A6004, 01/2008, A6003, 09/2007, and A6002-3, 09/2007
Products Sold
Lot Number/ Exp. Date A7003, 01/2009. A7002, 11/2008, A7001, 10/2008, A6005, 04/2008, A6004, 01/2008, A6003, 09/2007, and A6002-3, 09/2007
AmniSure International LLC is recalling AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure due to Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect". Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
Recommended Action
Per FDA guidance
AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026