Recall Z-1636-2020 ยท NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
Qiagen Sciences LLC
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
| Date | Feb 21, 2020 |
| Status | Terminated |
| Reason | An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute. |
| Root cause | Employee error |
| Action | On February 21, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the incorrect rinse time on the product's labeling, and reminded of the correct rinse time of 1 (one) minute. Customers were asked to immediately share the contents of the customer letter with all users of the AmniSure ROM Test in their facility to ensure awareness. Test users should refer to the instructions for use (IFU) included in each kit box. The firm is not asking for product to be returned. Customers were asked to complete and return an attached respons |
| Quantity | 1654 kit boxes |
| Distribution | Nationwide domestic distribution. Foreign distribution to 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 |