ROTEM ROTROL N recall in Canada: Medical device issue
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 needed for certain lots. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot numbers provided.
- Contact TEM Innovations for a new quality certificate.
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Affected products
ROTEM ROTROL N NORMAL CONTROL FOR THROMBOELASTOMETRY
Model: 503-24-CA
Lot: 42190401, 42242401, 42261401
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
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 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?
This recall involves ROTEM ROTROL N NORMAL CONTROL FOR THROMBOELASTOMETRY sold in Canada. It's being recalled because a target range reassignment is needed for certain lots. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check the lot numbers provided. Contact TEM Innovations for a new quality certificate.
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 August 2, 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 needed for certain lots. Stop using the product and follow the return/repair steps in the official notice.