AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, C
FDA device recall Z-0120-2008 · posted 2008-01-19 · Terminated
Recall details
- Recalling firm
- AmniSure International LLC
- 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"
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 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, Tur
- Date initiated
- 2007-10-03
- Date posted
- 2008-01-19
- Date terminated
- 2008-02-06
- Location
- Cambridge, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 (K030849) | N-Dia, Inc. | 2004-02-02 |