Z-1636-2020Class II

AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution...

Name: Z-1636-2020 AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution...
Creator: Qiagen Sciences LLC
Published: 2020-02-21
License: https://open.fda.gov/license/

Qiagen / initiated 2020-02-21 / Terminated / root cause: manufacturing process

FDA source

Qiagen Sciences LLC began a recall of 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... on 2020-02-21. FDA classified it as Class II and gives the reason as "An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1636-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-21
Posted: 2020-04-01
Terminated: 2020-10-05
Recalling firm: Qiagen
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)
Product code: NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1654 kit boxes
Distribution: Nationwide domestic distribution. Foreign distribution to Canada.
Product codes and lots: FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1636-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1636-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01

Product code NQM

K081767Class IAmnisure Fetal Membranes Rupture Test, Model Fmrt-1Amnisure International, LLC / cleared 2009-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)