IMMULITE/IMMULITE 1000 Systems — Class II medical device recall Z-1119-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-02-08, distributed nationwide. Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investi
| Recall number | Z-1119-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2016-12-21 |
| Classified | 2017-01-31 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, DE, DK, HR |
| Model numbers | 10380956, LKUP1 |
| Expiration dates | 2017-01-31, 2017-02-28, 2017-05-31 |
Product
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
Reason for recall
Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.