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)
- Company
- Qiagen Sciences Llc
- Recall Initiated
- February 21, 2020
- Terminated
- October 5, 2020
- Recall Number
- Z-1636-2020
- Quantity
- 1654 kit boxes
- Firm Location
- Germantown, MD
Reason for Recall
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Distribution
Nationwide domestic distribution. Foreign distribution to Canada.
Lot / Code Info
FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195
Root Cause
Employee error
Action Taken
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 response form.