Device product
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)
Z-1636-2020
Product summary
- Event
- Event 85122
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1654 kit boxes
- Official record key
device-enforcement:Z-1636-2020
Official wording
Reason: An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Code information: FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195
Distribution pattern: Nationwide domestic distribution. Foreign distribution to Canada.
Derived failure modes
-
Unknown
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.