AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
FDA Recall Z-0120-2008 · Posted 2008-01-19
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Recalling FirmAmniSure International LLC
Recall StatusTerminated
Product CodeJJX
Date Initiated2007-10-03
Date Terminated2008-02-06
Product Quantity319,976 units
Reason for Recall
Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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