SPOTCHECK System recall in Canada: Medical device performance issue
In plain language
This recall involves the SPOTCHECK System, a medical device sold in Canada. It's being recalled because of a possible defect in the TCA reagent, which may affect the device's performance. Healthcare professionals should provide supplemental TCA to ensure the reagent works as intended.
What to do
- Provide supplemental TCA to ensure the reagent works as intended.
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Affected products
SPOTCHECK System
Model: 81-8000-60K
Lot: 240113
Why this matters
Medical device performance issue
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: 240113
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 81-8000-60K
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?
Medical device performance issue
What should consumers do?
Provide supplemental TCA to ensure the reagent works as intended.
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. Medical device performance issue
When was this product recalled?
This product was recalled on August 21, 2024.
Is the Astoria-Pacific, Inc. brand affected by this recall?
Yes, Astoria-Pacific, Inc. products are affected by this recall. This recall involves the SPOTCHECK System, a medical device sold in Canada. It's being recalled because of a possible defect in the TCA reagent, which may affect the device's performance. Healthcare professionals should provide supplemental TCA to ensure the reagent works as intended.