Dimension Vista and EXL System Assay recall in Canada: inaccurate test results
In plain language
This recall involves the Dimension Vista System-Enzymatic Creatinine (ECREA) Assay and Dimension EXL System-Enzymatic Creatinine (EZCR) Assay sold in Canada. They are being recalled because they may provide falsely low creatinine results for patients taking phenindione. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot and model numbers provided.
- Return or dispose of it as instructed.
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Affected products
Dimension Vista System-Enzymatic Creatinine (ECREA) Assay
Model: K1270A
Lot: 18298AA, 18346AA, 19035AA, 19101AA, 19175AA, 19189AA, 19192AB, 19218AB, 19273AA
Dimension EXL System-Enzymatic Creatinine (EZCR) Assay
Model: 10471520
Lot: BC9345, ED0086, FB0122, FC9310, FD9164, GB9213, GC0024, GC0184, GD0218, GD9262
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: 18298AA, 18346AA, 19035AA, 19101AA, 19175AA, 19189AA, 19192AB, 19218AB, 19273AA, BC9345, ED0086, FB0122, FC9310, FD9164, GB9213, GC0024, GC0184, GD0218, GD9262
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 10471520, K1270A
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 the lot and model numbers provided. Return or dispose of it as instructed.
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 20, 2020.
Is the Dimension brand affected by this recall?
Yes, Dimension products are affected by this recall. This recall involves the Dimension Vista System-Enzymatic Creatinine (ECREA) Assay and Dimension EXL System-Enzymatic Creatinine (EZCR) Assay sold in Canada. They are being recalled because they may provide falsely low creatinine results for patients taking phenindione. Stop using the product and follow the return/repair steps in the official notice.