IMMAGE Immunochemistry System recall in Canada: Inaccurate test results
In plain language
This recall involves IMMAGE Immunochemistry System reagents sold in Canada. They are being recalled because they may provide inaccurate test results for patients with high lipid levels. Stop using the affected products and follow the return steps in the official notice.
What to do
- Stop using the affected reagents immediately.
- Contact Beckman Coulter Inc. for instructions.
- Return or dispose of the products as instructed.
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Affected products
IMMAGE Immunochemistry System C3 Complement C3 Reagent
Model: 446450
Lot: All lots
IMMAGE Immunochemistry System C4 Complement C4 Reagent
Model: 446490
Lot: All lots
IMMAGE Immunochemistry System HPT Haptoglobin Reagent
Model: 446480
Lot: All lots
IMMAGE Immunochemistry System IGA Immunoglobulin A Reagent
Model: 446460
Lot: All lots
IMMAGE Immunochemistry System IGM Immunoglobulin M Reagent
Model: 447610
Lot: All lots
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 446450, 446460, 446480, 446490, 447610
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 reagents immediately. Contact Beckman Coulter Inc. for instructions. Return or dispose of the products as instructed.
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 May 15, 2020.
Is the IMMAGE brand affected by this recall?
Yes, IMMAGE products are affected by this recall. This recall involves IMMAGE Immunochemistry System reagents sold in Canada. They are being recalled because they may provide inaccurate test results for patients with high lipid levels. Stop using the affected products and follow the return steps in the official notice.