ImmunoCAP Allergen recall in Canada: Test results may be inaccurate
In plain language
This recall involves ImmunoCAP Allergen c6, Amoxicilloyl and ImmunoCAP Allergen c5, Ampicilloyl medical devices sold in Canada. They are being recalled because stability specifications were not met, which could lead to inaccurate test results. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.
What to do
- Stop using the affected products immediately.
- Check the lot or serial numbers provided.
- Contact Somagen Diagnostics for return instructions.
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Affected products
ImmunoCAP Allergen c6, Amoxicilloyl
Model: 14-4451-01
Lot: 991D7, 991D8, 991D9, 991DA, 991DB, 991DC
ImmunoCAP Allergen c5, Ampicilloyl
Model: 14-4450-01
Lot: 990DS, 990DT, 990DU, 990DV, 990DW, 990DX, 990DY, 990DZ
Why this matters
Inaccurate 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: 990DS, 990DT, 990DU, 990DV, 990DW, 990DX, 990DY, 990DZ, 991D7, 991D8, 991D9, 991DA, 991DB, 991DC
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 14-4450-01, 14-4451-01
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?
Inaccurate test results
What should consumers do?
Stop using the affected products immediately. Check the lot or serial numbers provided. Contact Somagen Diagnostics for return instructions.
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. Inaccurate test results
When was this product recalled?
This product was recalled on January 12, 2018.
Is the ImmunoCAP Allergen brand affected by this recall?
Yes, ImmunoCAP Allergen products are affected by this recall. This recall involves ImmunoCAP Allergen c6, Amoxicilloyl and ImmunoCAP Allergen c5, Ampicilloyl medical devices sold in Canada. They are being recalled because stability specifications were not met, which could lead to inaccurate test results. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.