Chemstrip 10A and Urisys 1100 Analyzer recall in Canada: Inaccurate test results
In plain language
This recall involves Chemstrip 10A and Urisys 1100 Analyzer medical devices sold in Canada. They are being recalled because internal studies showed inaccurate test results for certain substances. Stop using the products and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Roche Diagnostics GMBH for return instructions.
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Affected products
Chemstrip 10A
Model: 11379208119
Lot: All lots
Urisys 1100 Analyzer
Model: 03617548001
Lot: All lots
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 03617548001, 11379208119
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. Contact Roche Diagnostics GMBH for return 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 June 14, 2018.