Medical device recall in Canada: Test kits may give incorrect results
In plain language
This recall involves Lipase OSR6x30, Uric Acid OSR6x98, and Enzymatic Creatinine OSR6x204 test kits used in Canada. They are being recalled because a common pain medication ingredient can interfere with the tests, leading to incorrect results. Stop using the affected products and follow the instructions from Health Canada.
What to do
- Stop using the affected products immediately.
- Contact the manufacturer for more information.
- Follow Health Canada's instructions for medical device recalls.
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Affected products
Lipase OSR6x30
Model: OSR6X30
Lot: More than 10 numbers, contact manufacturer.
Uric Acid OSR6x98
Model: OSR6x98
Lot: More than 10 numbers, contact manufacturer.
Enzymatic Creatinine OSR6x204
Model: OSR6X204
Lot: 1508 2431 2433 2434 2436 2438 2441
Why this matters
Incorrect 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: 1508 2431 2433 2434 2436 2438 2441, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: OSR6X204, OSR6X30, OSR6x98
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?
Incorrect test results
What should consumers do?
Stop using the affected products immediately. Contact the manufacturer for more information. Follow Health Canada's instructions for medical device recalls.
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. Incorrect test results
When was this product recalled?
This product was recalled on September 17, 2018.