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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 Testsee related information
Date Initiated by FirmMay 18, 2018
Date PostedJuly 13, 2018
Recall Status1 Terminated 3 on September 02, 2020
Recall NumberZ-2577-2018
Recall Event ID 80404
510(K)NumberK081767 
Product Classification Immunoassay for detection of amniotic fluid protein(s). - Product Code NQM
ProductAmniSure 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/
Manufacturer		 Qiagen Sciences, Inc.
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact
301-944-7000
Manufacturer Reason
for Recall		Potential for control line not appearing on the test strip
FDA Determined
Cause 2		Employee error
ActionOn 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 Commerce1620 kits
DistributionWorldwide - US Nationwide distribution an in the country of , Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NQM
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