Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure
Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for control line not appearing on the test strip"
Plain-English summary
Qiagen Sciences, Inc. is recalling 1,620 kits of the AmniSure ROM Test, a rapid, non-instrumented, qualitative immunochromatographic test used for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. The recall affects products labeled with Catalog Number FMRT-1-25 and Catalog Number FMRT-1-25-CA.
The recall was initiated due to a potential for the control line not appearing on the test strip. This defect may impact the reliability of the test results. The affected lots include UDI 14053228022319 (Lot Numbers 557016546, 557016547 & 5600115, Exp Date 7/28/2020) and UDI 14053228022333 (Lot Number 557016409, Exp Date 7/28/2020).
The product was distributed nationwide in the United States and in Canada. Consumers and healthcare providers should stop using the affected test kits and contact Qiagen Sciences for further instructions or a replacement.
The recalled product
- Product
- AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
- Manufacturer
- Qiagen Sciences, Inc.
- Affected units
- 1,620
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 (6)
- 1) UDI 14053228022319
- Lot Numbers - 557016546
- 557016547 & 5600115
- Exp Date 7/28/2020 2) UDI 14053228022333
- Lot Number - 557016409
- Exp Date 7/28/2020
Distribution
Distributed nationwide across the United States.
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