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U.S. Department of Health and Human Services

Class 2 Device Recall AmniSure ROM Test

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  Class 2 Device Recall AmniSure ROM Test see related information
Date Initiated by Firm February 21, 2020
Create Date April 01, 2020
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-1636-2020
Recall Event ID 85122
510(K)Number K081767  
Product Classification Immunoassay for detection of amniotic fluid protein(s). - Product Code NQM
Product AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
Code Information FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552  FMRT-1-10-US: Lot 563011618  FMRT-1-25-CA: Lot 563011195
Recalling Firm/
Manufacturer		 Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact QIAGEN Technical Services
800-344-3631
Manufacturer Reason
for Recall		 An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
FDA Determined
Cause 2		 Employee error
Action On February 21, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the incorrect rinse time on the product's labeling, and reminded of the correct rinse time of 1 (one) minute. Customers were asked to immediately share the contents of the customer letter with all users of the AmniSure ROM Test in their facility to ensure awareness. Test users should refer to the instructions for use (IFU) included in each kit box. The firm is not asking for product to be returned. Customers were asked to complete and return an attached response form.
Quantity in Commerce 1654 kit boxes
Distribution Nationwide domestic distribution. Foreign distribution to 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
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