ROTEM ROTROL N recall in Canada: Incorrect test results
In plain language
This recall involves ROTEM ROTROL N Normal Control for Thromboelastometry sold in Canada. It's being recalled because a target range reassignment is necessary for certain lot numbers, which could lead to incorrect test results. Healthcare professionals should use the new assigned ranges provided in the official notice.
What to do
- Stop using the product with the old ranges immediately.
- Check the lot numbers of your ROTEM ROTROL N and ROTEM ex-tem products.
- Use the new Quality Certificate and assigned ranges provided by TEM Innovations.
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Affected products
ROTEM ROTROL N Normal Control for Thromboelastometry
Model: 503-24-CA
Lot: 42190401, 42242401, 42261401
ROTEM ex-tem
Model: 503-05-CA
Lot: 42235001
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: 42190401, 42242401, 42261401, 42235001
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 503-05-CA, 503-24-CA
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 product with the old ranges immediately. Check the lot numbers of your ROTEM ROTROL N and ROTEM ex-tem products. Use the new Quality Certificate and assigned ranges provided by TEM Innovations.
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 August 9, 2019.
Is the ROTEM brand affected by this recall?
Yes, ROTEM products are affected by this recall. This recall involves ROTEM ROTROL N Normal Control for Thromboelastometry sold in Canada. It's being recalled because a target range reassignment is necessary for certain lot numbers, which could lead to incorrect test results. Healthcare professionals should use the new assigned ranges provided in the official notice.