Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2577-2018 — AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.

U.S. FDA — Device Enforcement · United States · 2018-05-18 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2577-2018
Date of alert: 2018-05-18
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Qiagen Sciences, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 14053228022319

Reported risk: Potential for control line not appearing on the test strip

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2577-2018 — AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.

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