Z-2577-2018Class I

AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA

Name: Z-2577-2018 AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA
Creator: Qiagen Sciences, Inc.
Published: 2018-05-18
License: https://open.fda.gov/license/

Qiagen / initiated 2018-05-18 / Terminated / root cause: manufacturing process

FDA source

Qiagen Sciences, Inc. began a recall of 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... on 2018-05-18. FDA classified it as Class I and gives the reason as "Potential for control line not appearing on the test strip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2577-2018
Classification: Class I
Status: Terminated
Initiated: 2018-05-18
Posted: 2018-07-13
Terminated: 2020-09-02
Recalling firm: Qiagen
Product: 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.
Product code: NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
Reason for recall: Potential for control line not appearing on the test strip
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 18, 2018 QIAGEN issued Urgent Voluntary Medical Device Recall notices and response forms to customers. Customers were advised to take the following actions: 1) Immediately discontinue use of all impacted lots and return all unused product to QIAGEN. 2) Share the Voluntary Medical Device Recall Notice with all users of the AmniSure ROM Test in your facility to ensure they are aware of this recall. 3) Use the Return Response form to confirm receipt of the notification and to record quantity of material to return. If you have any questions regarding this notice, please contact Technical Services at 1-800-344-3631.
Quantity in commerce: 1620 kits
Distribution: Worldwide - US Nationwide distribution an in the country of , Canada
Product codes and lots: 1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2577-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2577-2018	Class I	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-08

Product code NQM

K081767Class IAmnisure Fetal Membranes Rupture Test, Model Fmrt-1Amnisure International, LLC / cleared 2009-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)