FDA Medical Device Recalls (openFDA)
Qiagen Sciences LLC: 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)
- Recall number
- Z-1636-2020
- Recalling firm
- Qiagen Sciences LLC
- 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)
- Status
- Terminated
- Initiated
- 2020-02-21
- Posted
- not on file
- Terminated
- 2020-10-05
- Reason
- An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
- Root cause
- 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
- 1654 kit boxes
- Distribution
- Nationwide domestic distribution. Foreign distribution to Canada.
- Lot, serial or model codes
- FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195
- 510(k) numbers
- ["K081767"]
- PMA numbers
- not on file
- Product code
- NQM
- Firm FEI
- 3003572099
- Firm city
- Germantown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28