IMMULITE System and 1000 System - Turbo Intact PTH Assay (2018-03-26)
In plain language
This recall involves the IMMULITE System and IMMULITE 1000 System - Turbo Intact PTH Assay sold in Canada. It's being recalled because of a potential for failed adjustment slopes, which could affect test results. 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 246, 247, and 248.
- Contact Siemens Healthcare Diagnostics for further instructions.
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Affected products
IMMULITE SYSTEM - TURBO INTACT PTH ASSAY
Model: LSKPTZ
Lot: 246, 247, 248
IMMULITE 1000 SYSTEM - TURBO INTACT PTH ASSAY
Model: LSKPTZ
Lot: 246, 247, 248
Why this matters
Potential for 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: 246, 247, 248
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: LSKPTZ
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?
Potential for inaccurate test results
What should consumers do?
Stop using the product immediately. Check lot numbers 246, 247, and 248. Contact Siemens Healthcare Diagnostics for further instructions.
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. Potential for inaccurate test results
When was this product recalled?
This product was recalled on May 11, 2018.
Is the IMMULITE brand affected by this recall?
Yes, IMMULITE products are affected by this recall. This recall involves the IMMULITE System and IMMULITE 1000 System - Turbo Intact PTH Assay sold in Canada. It's being recalled because of a potential for failed adjustment slopes, which could affect test results. Stop using the product and follow the return/repair steps in the official notice.