UniCel DxI 600, 800 Access Immunoassay System - Thyroglobulin Antibody II (2019-02-09)
In plain language
This recall involves UniCel DxI 600 and 800 Access Immunoassay Systems - Thyroglobulin Antibody II sold in Canada. It's being recalled because it may give falsely decreased test 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 and lot numbers.
- Contact Beckman Coulter for further instructions.
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Affected products
UniCel DxI 800 Access Immunoassay System - Thyroglobulin Antibody II
Model: A32898
Lot: 831710, 831759, 832055, 832163
Access System - Thyroglobulin Antibody II
Model: A32898
Lot: 831710, 831759, 832055, 832163
UniCel DxI 600 Access Immunoassay System - Thyroglobulin Antibody II
Model: A32898
Lot: 831710, 831759, 832055, 832163
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: 831710, 831759, 832055, 832163
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: A32898
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 and lot numbers. Contact Beckman Coulter for further 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 medical test results
When was this product recalled?
This product was recalled on March 8, 2019.
Is the UniCel DxI brand affected by this recall?
Yes, UniCel DxI products are affected by this recall. This recall involves UniCel DxI 600 and 800 Access Immunoassay Systems - Thyroglobulin Antibody II sold in Canada. It's being recalled because it may give falsely decreased test results. Stop using the product and follow the return/repair steps in the official notice.