ADVIA Centaur System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay and ADVIA Centaur CP System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay (2017-12-21)
In plain language
This recall involves ADVIA Centaur System and ADVIA Centaur CP System medical devices sold in Canada. They are being recalled because they may not properly expire certain reagents, which could lead to inaccurate test results. Stop using the affected products and follow the instructions from the manufacturer.
What to do
- Stop using the affected products immediately.
- Check the model and lot numbers of your devices.
- Contact Siemens Healthcare Diagnostics Inc. for further instructions.
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Affected products
ADVIA Centaur CP System - B-Type Natriuretic Peptide (BNP) Assay
Model: 02816138, 02816634
Lot: Kit Lot Ending: 192, 193, 196
ADVIA Centaur System - B-Type Natriuretic Peptide (BNP) Assay
Model: 02816138, 02816634
Lot: Kit Lot Ending: 192, 193, 196
ADVIA Centaur System - Tsh3-Ultra (Tsh3-Ul) Assay
Model: 06491072, 06491080
Lot: Kit Lot Ending: 298 & 301
ADVIA Centaur CP System - Tsh3-Ultra (Tsh3-Ul) Assay
Model: 06491072, 06491080
Lot: Kit Lot Ending: 298 & 301
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: Kit Lot Ending: 192, 193, 196, Kit Lot Ending: 298 & 301
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 02816138, 02816634, 06491072, 06491080
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 affected products immediately. Check the model and lot numbers of your devices. Contact Siemens Healthcare Diagnostics Inc. 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 January 12, 2018.
Is the ADVIA Centaur brand affected by this recall?
Yes, ADVIA Centaur products are affected by this recall. This recall involves ADVIA Centaur System and ADVIA Centaur CP System medical devices sold in Canada. They are being recalled because they may not properly expire certain reagents, which could lead to inaccurate test results. Stop using the affected products and follow the instructions from the manufacturer.