ABL800 Flex System recall in Canada: Performance issues
In plain language
This recall involves the ABL800 Flex System, a medical device used in healthcare settings. It's being recalled because of potential performance issues that could lead to inaccurate test results. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer, Radiometer Medical Aps, for additional information.
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Affected products
ABL800 Flex System
Model: 393-800, 393-801
Lot: More than 10 numbers, contact manufacturer
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: More than 10 numbers, contact manufacturer
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 393-800, 393-801
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 ABL800 Flex System, a medical device used in healthcare settings. It's being recalled because of potential performance issues that could lead to inaccurate test results. Healthcare professionals should contact the manufacturer for more information.
What should consumers do?
Contact the manufacturer, Radiometer Medical Aps, for additional information.
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 May 24, 2022.
Is the Radiometer Medical Aps brand affected by this recall?
Yes, Radiometer Medical Aps products are affected by this recall. This recall involves the ABL800 Flex System, a medical device used in healthcare settings. It's being recalled because of potential performance issues that could lead to inaccurate test results. Healthcare professionals should contact the manufacturer for more information.