Dimension Gentamicin Assay recall in Canada: Inaccurate test results
In plain language
This recall involves Dimension Gentamicin Assays used with various Siemens medical systems in Canada. They are being recalled because they may provide inaccurate test results for patient samples. Stop using the affected products and follow the instructions from Siemens Healthcare Diagnostics.
What to do
- Stop using the affected products immediately.
- Check the lot or serial numbers of your Dimension Gentamicin Assays.
- Contact Siemens Healthcare Diagnostics for further instructions.
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Affected products
Dimension Vista System - Gentamicin Assay
Model: K4012
Lot: 12269BD, 17135BC, 17150BF, 17159BD, 17178AC, 17312BB
Dimension Clinical Chemistry System - Gentamicin
Model: DF12
Lot: BB8159, EB8115, FB8275
Dimension Xpand System - Gentamicin (Gent) Assay
Model: DF12
Lot: BB8159, EB8115, FB8275
Dimension EXL System - Gentamicin (Gent) Assay
Model: DF12
Lot: BB8159, EB8115, FB8275
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: 12269BD, 17135BC, 17150BF, 17159BD, 17178AC, 17312BB, BB8159, EB8115, FB8275
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: DF12, K4012
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 lot or serial numbers of your Dimension Gentamicin Assays. Contact Siemens Healthcare Diagnostics 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 May 25, 2018.
Is the Dimension brand affected by this recall?
Yes, Dimension products are affected by this recall. This recall involves Dimension Gentamicin Assays used with various Siemens medical systems in Canada. They are being recalled because they may provide inaccurate test results for patient samples. Stop using the affected products and follow the instructions from Siemens Healthcare Diagnostics.