Chemstrip 5, Chemstrip 7 and Urisys 1100 (2018-08-27)
In plain language
This recall involves Chemstrip 5, Chemstrip 7, and Urisys 1100 medical devices sold in Canada. They are being recalled because a deviation in measuring performance can lead to false negative results for certain tests. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Roche Diagnostics for further instructions.
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Affected products
Chemstrip 5
Model: 11893467119
Lot: All lots.
Chemstrip 7
Model: 11008552119
Lot: All lots.
Urisys 1100
Model: 03617548001
Lot: All lots.
Why this matters
False negative 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, 11008552119, 11893467119
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?
False negative test results
What should consumers do?
Stop using the product immediately. Contact Roche 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. False negative test results
When was this product recalled?
This product was recalled on November 28, 2018.
Is the Chemstrip, Urisys brand affected by this recall?
Yes, Chemstrip, Urisys products are affected by this recall. This recall involves Chemstrip 5, Chemstrip 7, and Urisys 1100 medical devices sold in Canada. They are being recalled because a deviation in measuring performance can lead to false negative results for certain tests. Stop using the product and follow the return steps in the official notice.