Z-1636-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- February 21, 2020
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1654 kit boxes
Product Description
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)
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 Pattern
Nationwide domestic distribution. Foreign distribution to Canada.
Code Information
FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195