Beckman Coulter Immunochemistry System recall in Canada: performance issue
In plain language
This recall involves Beckman Coulter Au2700/5400 Immunochemistry Systems - Transferrin Assay sold in Canada. It's being recalled because the transferrin reagent does not meet stability claims, which may affect test results. Healthcare professionals should contact the manufacturer for additional information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Beckman Coulter Au2700 Immunochemistry System - Transferrin Assay
Model: OSR6152
Lot: 2573
Beckman Coulter Au Immunochemistry System - Transferrin Assay
Model: OSR6152
Lot: 2573
Beckman Coulter Au5400 Immunochemistry System - Transferrin Assay
Model: OSR6152
Lot: 2573
Why this matters
Performance issue affecting medical device accuracy
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: 2573
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: OSR6152
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?
Performance issue affecting medical device accuracy
What should consumers do?
Contact the manufacturer if you require additional information.
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. Performance issue affecting medical device accuracy
When was this product recalled?
This product was recalled on September 18, 2023.
Is the BECKMAN COULTER, INC. brand affected by this recall?
Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves Beckman Coulter Au2700/5400 Immunochemistry Systems - Transferrin Assay sold in Canada. It's being recalled because the transferrin reagent does not meet stability claims, which may affect test results. Healthcare professionals should contact the manufacturer for additional information.