IMMAGE Immunochemistry System recall in Canada: may cause false low results
In plain language
This recall involves the IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Cal sold in Canada. It's being recalled because it may generate false low results for patient samples with high IGE concentrations. This could delay diagnosis and treatment if not evaluated with other clinical tests. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Beckman Coulter Inc. for more information.
- Follow the instructions provided by the manufacturer.
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Affected products
IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Cal
Model: 474620
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Delayed diagnosis and treatment
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 474620
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?
Delayed diagnosis and treatment
What should consumers do?
Stop using the product immediately. Contact Beckman Coulter Inc. for more information. Follow the instructions provided by the manufacturer.
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. Delayed diagnosis and treatment
When was this product recalled?
This product was recalled on October 3, 2019.
Is the IMMAGE brand affected by this recall?
Yes, IMMAGE products are affected by this recall. This recall involves the IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Cal sold in Canada. It's being recalled because it may generate false low results for patient samples with high IGE concentrations. This could delay diagnosis and treatment if not evaluated with other clinical tests. Stop using the product and follow the return/repair steps in the official notice.