Qiagen AmniSure ROM Test Recalled for Incorrect Rinse Time Labeling
Qiagen Sciences LLC is recalling AmniSure ROM Test kits because the packaging displays an incorrect rinse time of 30 seconds instead of the correct 1 minute.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when the hazard is a labeling error without reported injuries or illnesses.
Plain-English summary
Qiagen Sciences LLC is recalling specific lots of the AmniSure ROM Test, a medical device used for testing. The recall involves 1,654 kit boxes distributed nationwide in the United States and in Canada.
The recall was initiated because an image on the associated polybag contains an incorrect rinse time of 30 seconds. The correct rinse time for the test is 1 minute. This labeling error may lead to improper use of the device.
Affected lots include FMRT-1-25-US (Lots 563010976, 563011620, 563011164, 5660397, 5660552), FMRT-1-10-US (Lot 563011618), and FMRT-1-25-CA (Lot 563011195). Users should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- 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)
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- Affected units
- 1,654
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- FMRT-1-25-US: Lots 563010976
- 563011620
- 563011164
- 5660397
- 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195
Distribution
Distributed nationwide across the United States.
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