ARCHITECT I SYSTEM - EBV VCA IgM Calibrator (2020-11-03)
In plain language
This recall involves the ARCHITECT I SYSTEM - EBV VCA IgM Calibrator (lot 08159BE00) sold in Canada. It's being recalled because it may show reduced signal, leading to inaccurate test results. This could cause false grayzone or false reactive patient results. Stop using the affected product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot number 08159BE00.
- Contact Abbott for further instructions.
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Affected products
ARCHITECT I SYSTEM - EBV VCA IgM Calibrator
Model: 3P66-01
Lot: 08159BE00
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: 08159BE00
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 3P66-01
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 product immediately. Check the lot number 08159BE00. Contact Abbott 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 test results
When was this product recalled?
This product was recalled on November 13, 2020.
Is the ARCHITECT I SYSTEM brand affected by this recall?
Yes, ARCHITECT I SYSTEM products are affected by this recall. This recall involves the ARCHITECT I SYSTEM - EBV VCA IgM Calibrator (lot 08159BE00) sold in Canada. It's being recalled because it may show reduced signal, leading to inaccurate test results. This could cause false grayzone or false reactive patient results. Stop using the affected product and follow the return steps in the official notice.