Medical device recall in Canada: Cortisol Assay may cause inaccurate results
In plain language
This recall involves the Access System - Cortisol Assay and UniCel DxI 600 and 800 Access Immunoassay System - Cortisol Assay sold in Canada. It's being recalled because cross-contamination may lead to falsely decreased patient results. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Access System - Cortisol Assay
Model: 33600
Lot: 831755
UniCel DxI 600 Access Immunoassay System - Cortisol Assay
Model: 33600
Lot: 831755
UniCel DxI 800 Access Immunoassay System - Cortisol Assay
Model: 33600
Lot: 831755
Why this matters
Inaccurate medical 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: 831755
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 33600
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 medical test results
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it 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 medical test results
When was this product recalled?
This product was recalled on October 19, 2018.
Is the Access System brand affected by this recall?
Yes, Access System products are affected by this recall. This recall involves the Access System - Cortisol Assay and UniCel DxI 600 and 800 Access Immunoassay System - Cortisol Assay sold in Canada. It's being recalled because cross-contamination may lead to falsely decreased patient results. Stop using the product and follow the return/repair steps in the official notice.