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.
FDA Recall Z-2577-2018 · Posted 2018-07-13
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Recalling FirmQiagen Sciences, Inc.
Recall StatusTerminated
Product CodeNQM
Date Initiated2018-05-18
Date Terminated2020-09-02
Product Quantity1620 kits
Reason for Recall
Potential for control line not appearing on the test strip
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide - US Nationwide distribution an in the country of , Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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