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U.S. Department of Health and Human Services

Class 2 Device Recall AmniSure

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  Class 2 Device Recall AmniSure see related information
Date Initiated by Firm October 03, 2007
Date Posted January 19, 2008
Recall Status1 Terminated 3 on February 06, 2008
Recall Number Z-0120-2008
Recall Event ID 44937
510(K)Number K030849  
Product Classification Fetal Membrane Rupture Test - Product Code JJX
Product AmniSure ROM Test, Fetal Membrane Rupture Test for
In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
Code Information Lot Number/ Exp. Date  A7003, 01/2009. A7002, 11/2008,  A7001, 10/2008, A6005, 04/2008,  A6004, 01/2008, A6003, 09/2007, and  A6002-3, 09/2007 
Recalling Firm/
Manufacturer		 AmniSure International LLC
31 Sacramento St # 5
Cambridge MA 02138-1820
For Additional Information Contact
617-234-4441
Manufacturer Reason
for Recall		 Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"
FDA Determined
Cause 2		 Device Design
Action AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.
Quantity in Commerce 319,976 units
Distribution Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador
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 = JJX and Original Applicant = N-DIA, INC.
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