FDA-Device2020-04-08Class II
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)
Qiagen Sciences LLC
Hazard
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Sold states
Nationwide domestic distribution. Foreign distribution to Canada.
Affected count
1654 kit boxes
Manufactured in
19300 Germantown Rd, N/A, Germantown, MD, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2020Don't want to check this manually?
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