IMMULITE and IMMULITE 1000 System recall in Canada: Inaccurate test results
In plain language
This recall involves IMMULITE and IMMULITE 1000 System Prostate-Specific Antigen (PSA) Assays sold in Canada. They are being recalled because they may give falsely low test results. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Contact Siemens Healthcare Diagnostics for instructions.
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Affected products
IMMULITE System- Prostate-Specific Antigen (PSA) Assay
Model: LKPS1
Lot: 0450
IMMULITE 1000 System - Prostate-Specific Antigen (PSA) Assay
Model: LKPS1
Lot: 0450
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: 0450
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: LKPS1
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 model and lot numbers. Contact Siemens Healthcare Diagnostics for 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 July 27, 2018.
Is the IMMULITE brand affected by this recall?
Yes, IMMULITE products are affected by this recall. This recall involves IMMULITE and IMMULITE 1000 System Prostate-Specific Antigen (PSA) Assays sold in Canada. They are being recalled because they may give falsely low test results. Stop using the product and follow the return steps in the official notice.