IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen — Class II medical device recall Z-0885-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-12-28, distributed nationwide. Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not
| Recall number | Z-0885-2017 |
|---|---|
| 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 | 2016-11-18 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AW, BD, BE, BG, BO, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HN, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JO, JP, KR, LB, LT, LV, MX, MY, NI, NL, PA, PE, PH, PK, PL, PT, PY, RO, RS, SA, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, ZA |
| Lot numbers | 408, 409, 410, D112, D123, D124, L2KPS2/L2KPS6, L2KPTS2/L2KPTS6 |
| Model numbers | 10380986, 10380996, 10706281, 10706282, L2KPS2, L2KPS6, L2KPTS2, L2KPTS6 |
Product
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi 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
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
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.