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.
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
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.
The polybag shows an incorrect rinse time of 30 seconds instead of 1 minute. If users rinse for too short a time, the test may not work properly, leading to inaccurate results.
Pregnant women using AmniSure ROM Test kits with the specified model numbers and lots. Those who have the kits with incorrect rinse time instructions are most at risk.
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.
Look for a rinse time of 30 seconds on the polybag. If present, the kit is affected.
The polybag shows an incorrect rinse time of 30 seconds instead of 1 minute.
Check the rinse time on the polybag. If it shows 30 seconds, the kit is affected and you should stop using it.
The recall includes specific US and Canadian model numbers and lots as listed in the product description.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-1636-2020 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-1636-2020 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
