ARCHITECT Hemoglobin A1c recall in Canada: Inaccurate test results
In plain language
This recall involves the ARCHITECT Hemoglobin A1c medical device sold in Canada. It's being recalled because it may provide inaccurate test results for patients with high levels of fetal hemoglobin. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check lot numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
ARCHITECT Hemoglobin A1c
Model: 4P52-21
Lot: 50007UQ10, 50030UQ10, 50031UQ10, 50279UQ12, 50280UQ12, 50281UQ12, 50282UQ12, 50613UQ02, 50614UQ02, 50615UQ02, 50616UQ02, 50884UQ04, 51177UQ06, 51457UQ08
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: 50007UQ10, 50030UQ10, 50031UQ10, 50279UQ12, 50280UQ12, 50281UQ12, 50282UQ12, 50613UQ02, 50614UQ02, 50615UQ02, 50616UQ02, 50884UQ04, 51177UQ06, 51457UQ08
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 4P52-21
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 lot numbers if provided. Return, repair, 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 12, 2018.
Is the ARCHITECT brand affected by this recall?
Yes, ARCHITECT products are affected by this recall. This recall involves the ARCHITECT Hemoglobin A1c medical device sold in Canada. It's being recalled because it may provide inaccurate test results for patients with high levels of fetal hemoglobin. Stop using the product and follow the return/repair steps in the official notice.