Recall Z-0120-2008
AmniSure International LLC · initiated October 3, 2007
Product
AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
Codes / lots: 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
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"
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0120-2008
- Initiated
- October 3, 2007
- Posted by FDA
- January 19, 2008
- Terminated
- February 6, 2008
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- 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
- Recalling firm
- AmniSure International LLC, Cambridge, MA