Recall Z-2577-2018 ยท NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
Qiagen Sciences, Inc.
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
| Date | Jul 13, 2018 (initiated May 18, 2018) |
| Status | Terminated |
| Reason | Potential for control line not appearing on the test strip |
| Root cause | Employee error |
| Action | On May 18, 2018 QIAGEN issued Urgent Voluntary Medical Device Recall notices and response forms to customers. Customers were advised to take the following actions: 1) Immediately discontinue use of all impacted lots and return all unused product to QIAGEN. 2) Share the Voluntary Medical Device Recall Notice with all users of the AmniSure ROM Test in your facility to ensure they are aware of this recall. 3) Use the Return Response form to confirm receipt of the notification and to record quantity of material to return. If you have any questions regarding this notice, please contact Technical |
| Quantity | 1620 kits |
| Distribution | Worldwide - US Nationwide distribution an in the country of , Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081767 | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 Amnisure International, LLC, Jan 9, 2009 |