Phadia System - ELIA DSDNA recall in Canada: potential for false test results
In plain language
This recall involves the Phadia 100 System - ELIA DSDNA and Phadia 250 System - ELIA DSDNA, medical devices used in Canada. They are being recalled because they may produce false positive test results. Stop using the affected product and follow the instructions from the manufacturer.
What to do
- Stop using the product immediately.
- Check the lot number BFA3Y/0142 and model number 14-5500-01.
- Contact Phadia AB for further instructions.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
PHADIA 100 SYSTEM- ELIA DSDNA
Model: 14-5500-01
Lot: BFA3Y/0142
Phadia 250 System- ELIA DSDNA
Model: 14-5500-01
Lot: BFA3Y/0142
Why this matters
Potential for false positive test results
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: BFA3Y/0142
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 14-5500-01
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?
Potential for false positive test results
What should consumers do?
Stop using the product immediately. Check the lot number BFA3Y/0142 and model number 14-5500-01. Contact Phadia AB for further instructions.
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?
Yes, there may be a health risk. Potential for false positive test results
When was this product recalled?
This product was recalled on December 14, 2020.
Is the Phadia System brand affected by this recall?
Yes, Phadia System products are affected by this recall. This recall involves the Phadia 100 System - ELIA DSDNA and Phadia 250 System - ELIA DSDNA, medical devices used in Canada. They are being recalled because they may produce false positive test results. Stop using the affected product and follow the instructions from the manufacturer.