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U.S. Department of Health and Human Services

Class 1 Device Recall AmniSure Rupture of (fetal) Membrane Test

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  Class 1 Device Recall AmniSure Rupture of (fetal) Membrane Test see related information
Date Initiated by Firm May 18, 2018
Date Posted July 13, 2018
Recall Status1 Terminated 3 on September 02, 2020
Recall Number Z-2577-2018
Recall Event ID 80404
510(K)Number K081767  
Product Classification Immunoassay for detection of amniotic fluid protein(s). - Product Code NQM
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.
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 
Recalling Firm/
Qiagen Sciences, Inc.
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact
Manufacturer Reason
for Recall
Potential for control line not appearing on the test strip
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQM and Original Applicant = AMNISURE INTERNATIONAL, LLC