IRISpec CA/CB/CC recall in Canada: Performance issues
In plain language
This recall involves IRISpec CA/CB/CC medical devices sold in Canada. They are being recalled due to performance issues that may cause inaccurate test results. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
- Repeat QC runs if they fail.
- Ensure QC runs pass successfully before running patient samples.
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Affected products
IRISpec CA/CB/CC
Model: 800-7702
Lot: 432-24 and higher
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: 432-24 and higher
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 800-7702
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 IRISpec CA/CB/CC medical devices sold in Canada. They are being recalled due to performance issues that may cause inaccurate test results. Healthcare professionals should contact the manufacturer for more information.
What should consumers do?
Contact the manufacturer if you require additional information. Repeat QC runs if they fail. Ensure QC runs pass successfully before running patient samples.
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 July 26, 2024.
Is the Beckman Coulter Ireland, Inc. brand affected by this recall?
Yes, Beckman Coulter Ireland, Inc. products are affected by this recall. This recall involves IRISpec CA/CB/CC medical devices sold in Canada. They are being recalled due to performance issues that may cause inaccurate test results. Healthcare professionals should contact the manufacturer for more information.