Medical device recall in Canada: Immulite System- IGF-1 Assay
In plain language
This recall involves Immulite System- IGF-1 (Insulin like Growth Hormone) - 1000 and 2000 Assays sold in Canada. It's being recalled because the statistical method used for reference range data was updated for better accuracy. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers.
- Return, repair, or dispose of it as instructed.
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Affected products
Immulite 2000 System - IGF-1 (Insulin like Growth Hormone) Assay
Model: L2KIGF2
Lot: Not applicable
Immulite System - IGF-1 (Insulin like Growth Hormone) Assay
Model: LKIGF1
Lot: Not applicable
Immulite 1000 System - IGF-1 Assay
Model: LKIGF1
Lot: Not applicable
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: Not applicable
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: L2KIGF2, LKIGF1
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?
This recall involves Immulite System- IGF-1 (Insulin like Growth Hormone) - 1000 and 2000 Assays sold in Canada. It's being recalled because the statistical method used for reference range data was updated for better accuracy. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers. 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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on January 8, 2018.
Is the Immulite System brand affected by this recall?
Yes, Immulite System products are affected by this recall. This recall involves Immulite System- IGF-1 (Insulin like Growth Hormone) - 1000 and 2000 Assays sold in Canada. It's being recalled because the statistical method used for reference range data was updated for better accuracy. Stop using the product and follow the return/repair steps in the official notice.