Home / Recalls / Qiagen Sciences, Inc. / Z-2577-2018

Z-2577-2018 Class I Terminated

Recalled by Qiagen Sciences, Inc. — Germantown, MD

Recall Details

Product Type
Devices
Report Date
August 15, 2018
Initiation Date
May 18, 2018
Termination Date
September 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1620 kits

Product Description

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.

Reason for Recall

Potential for control line not appearing on the test strip

Distribution Pattern

Worldwide - US Nationwide distribution an in the country of , Canada

Code Information

1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020

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  • Z-1683-2023 Class II — QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR t (April 28, 2023)
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  • Z-0951-2022 Class II — therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) (February 25, 2022)
  • Z-0952-2022 Class II — therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the US (February 25, 2022)
  • Z-1746-2022 Class II — QIAcube Connect MDx, Model No. 9003070 (November 21, 2021)