AmniSure ROM Test recall in Canada: Incorrect instructions
In plain language
This recall involves the AmniSure ROM Test sold in Canada. It's being recalled because the instructions on the product packaging have an incorrect rinse time. Healthcare professionals should stop using the product and follow the correction notice from the manufacturer.
What to do
- Stop using the affected product immediately.
- Check the lot number of your AmniSure ROM Test kits.
- Follow the urgent correction notice provided by Qiagen.
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Affected products
AmniSure ROM Test
Model: FMRT-1-25
Lot: 563011195
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 563011195
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: FMRT-1-25
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves the AmniSure ROM Test sold in Canada. It's being recalled because the instructions on the product packaging have an incorrect rinse time. Healthcare professionals should stop using the product and follow the correction notice from the manufacturer.
What should consumers do?
Stop using the affected product immediately. Check the lot number of your AmniSure ROM Test kits. Follow the urgent correction notice provided by Qiagen.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on April 15, 2020.
Is the AmniSure brand affected by this recall?
Yes, AmniSure products are affected by this recall. This recall involves the AmniSure ROM Test sold in Canada. It's being recalled because the instructions on the product packaging have an incorrect rinse time. Healthcare professionals should stop using the product and follow the correction notice from the manufacturer.