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Siemens IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) - safety alert
Official notice
20 Nov 2024
Last checked
20 Nov 2024
An official FDA notice concerns Siemens IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) - safety alert. An official FDA notice concerns IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282). The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-11-20. Lots: D164, D166. Recall numbers: Z-0464-2025. Check the official notice for the complete list. Published 2024-11-20.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
7,332
Recall number
Z-0464-2025
Official notice
2024-11-20
The hazard
The hazard
An official FDA notice concerns IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282). The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-11-20. Lots: D164, D166. Recall numbers: Z-0464-2025. Check the official notice for the complete list.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Siemens. Contact: Siemens Healthcare Diagnostics, Inc..
Source & status
Source & status
Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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