Lower risk Medical device recall · FDA · Published February 21, 2020

Qiagen AmniSure ROM Test Recall: Incorrect Rinse Time Risk

Qiagen recalls AmniSure ROM Test kits with incorrect rinse time instructions. The correct rinse time is 1 minute, not 30 seconds. Affected kits include specific US and Canadian models.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1636-2020Medical device Qiagen ›

Lower-risk recall

An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.

Take action

Contact the company

Recalling firmQiagen Sciences LLC19300 Germantown Rd · Germantown, MD 20874-1415

✎ GovInfoNow plain-language explainer

Qiagen is recalling AmniSure ROM Test kits because the polybag shows an incorrect rinse time of 30 seconds instead of 1 minute. This could lead to inaccurate test results if the rinse time is too short. Read more at govinfonow.com/recall/65797-qiagen-amnisure-rom-test-recall-incorrect-rinse-time-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65797-qiagen-amnisure-rom-test-recall-incorrect-rinse-time-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1636-2020

Cite this page

“Qiagen AmniSure ROM Test Recall: Incorrect Rinse Time Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65797-qiagen-amnisure-rom-test-recall-incorrect-rinse-time-risk. Based on FDA recall #Z-1636-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1636-2020%22&limit=1).

Qiagen Sciences LLC recalled AmniSure ROM Test kits on Feb. 21, 2020, according to the FDA. The hazard is an incorrect rinse time of 30 seconds shown on the polybag image instead of the correct one minute.

How to tell if you have it

Brand: Qiagen
Product: AmniSure ROM Test
Material No. FMRT-1-25-US (US Distribution, 25 tests/box); Lots 563010976, 563011620, 563011164, 5660397, 5660552
Material No. FMRT-1-10-US (US Distribution, 10 tests/box); Lot 563011618
Material No. FMRT-1-25-CA (Canadian Distribution; 25 tests/box); Lot 563011195

The hazard

An image on the associated polybag contains an incorrect rinse time of 30 seconds. The correct rinse time is one minute.

Context

GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Other recent recalls include the Qiagen QIAstat-Dx Respiratory Panel Plus (March 12, 2025), the Qiagen QIAcube Connect MDx (June 3, 2024), and the Qiagen EZ2 Connect MDx-IVD (March 4, 2024).

How to tell if you have this one

Check the polybag for a rinse time of 30 seconds. Affected kits include US Distribution (25 tests/box) with lots 563010976, 563011620, 563011164, 5660397, 5660552 and 10 tests/box with lot 563011618. Canadian Distribution (25 tests/box) with lot 563011195.

Brand
Qiagen
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Rinse Time on Polybag
Look for a rinse time of 30 seconds on the polybag. If present, the kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide domestic distribution. Foreign distribution to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Feb 21, 2020Firm started the recall
Apr 1, 2020FDA classified it Class II
Apr 8, 2020Published in FDA’s Enforcement Report
Oct 5, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65797-qiagen-amnisure-rom-test-recall-incorrect-rinse-time-risk">Qiagen AmniSure ROM Test Recall: Incorrect Rinse Time Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1636-2020 (February 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1636-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.