AmniSure ROM Test under the following labels: 1) recall
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…
Why was AmniSure ROM Test under the following labels: 1) recalled?
Potential for control line not appearing on the test strip
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020
- 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…
- Recalling firm
- Qiagen Sciences, Inc.
- Quantity
- 1620 kits
- Distribution
- Worldwide - US Nationwide distribution an in the country of , Canada
- Recall date
- August 15, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)