FDA-Device2024-11-20Class II
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Siemens Healthcare Diagnostics, Inc.
Hazard
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Sold states
Worldwide - US Nationwide distribution.
Affected count
7,332 units
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2025Don't want to check this manually?
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