IMMULITE Progesterone Assay recall in Canada: inaccurate test results
In plain language
This recall involves IMMULITE 1000 and 2000 System- Progesterone Assays sold in Canada. They are being recalled because they may give inaccurate low progesterone results. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.
What to do
- Stop using the affected products immediately.
- Contact Siemens Healthcare Diagnostics for instructions.
- Return or dispose of the products as instructed.
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Affected products
IMMULITE 1000 System- Progesterone Assay
Model: LKPW1
Lot: More than 10 numbers, contact manufacturer.
IMMULITE 2000 System- Progesterone Assay
Model: L2KPW2, L2KPW6
Lot: More than 10 numbers, contact manufacturer.
IMMULITE System- Progesterone Assay
Model: LKPW1
Lot: More than 10 numbers, contact manufacturer.
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: L2KPW2, L2KPW6, LKPW1
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 affected products immediately. Contact Siemens Healthcare Diagnostics for instructions. Return or dispose of the products 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 July 26, 2019.
Is the IMMULITE brand affected by this recall?
Yes, IMMULITE products are affected by this recall. This recall involves IMMULITE 1000 and 2000 System- Progesterone Assays sold in Canada. They are being recalled because they may give inaccurate low progesterone results. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.