Medical device recall in Canada: ABL90 Flex Analyzers may give biased results
In plain language
This recall involves ABL90 Flex and ABL90 Flex Plus Analyzers sold in Canada. They are being recalled because a defect in the hemolyzer unit may cause biased bilirubin results. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Radiometer Medical Aps for more information.
- Follow the manufacturer's instructions for return or repair.
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Affected products
ABL90 Flex - Analyzer
Model: 393-090
Lot: More than 10 numbers, contact manufacturer.
ABL90 Flex Plus
Model: 393-092
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Biased medical 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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 393-090, 393-092
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?
Biased medical test results
What should consumers do?
Stop using the product immediately. Contact Radiometer Medical Aps for more information. Follow the manufacturer's instructions for return or repair.
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. Biased medical test results
When was this product recalled?
This product was recalled on January 6, 2020.