Reported Apr 8, 2020 · Terminated
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10…
Qiagen Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
AmniSure ROM TestMaterial Nos. FMRT-1-25-US (US Distribution25 tests/box)FMRT-1-10-US (US Distribution10 tests/box)FMRT-1-25-CA (Canadian Distribution25 tests/box)
- Lot codes and dates
- FMRT-1-25-US
Lots 56301097656301162056301116456603975660552
- FMRT-1-10-USLot 563011618
- FMRT-1-25-CALot 563011195
- FMRT-1-25-US
- Amount recalled
- 1654 kit boxes
Where it was sold
- Nationwide
Why it was recalled
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
This product could cause temporary or reversible health problems — stop using it.
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