Recall Z-0120-2008 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
AmniSure International LLC
AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
| Date | Jan 19, 2008 (initiated Oct 3, 2007) |
| Status | Terminated |
| Reason | Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect" |
| Root cause | Device Design |
| 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. |
| Quantity | 319,976 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030849 | AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 N-Dia, Inc., Feb 2, 2004 |