IMMULITE 2000 PSA assay does not meet high-dose analytical performance claim
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves a diagnostic assay not meeting its performance specification, which could affect test accuracy and patient care decisions. Per recall severity criteria, this is a risk-of-harm product without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain IMMULITE 2000 PSA assay units (Catalog Numbers L2KPTS2(D) and L2KPTS6(D)) affecting approximately 7,332 units with nationwide distribution in the US and worldwide distribution.
The IMMULITE 2000 PSA assay is an in vitro diagnostic device used to measure prostate-specific antigen levels for prostate cancer screening and monitoring. The affected devices do not meet the high-dose hook effect performance specification as stated in the Instructions for Use, meaning the assay may not perform correctly when testing samples with very high PSA concentrations.
Patients or healthcare providers who have received results from these devices should consult with their healthcare provider about their test results. Healthcare providers may need to verify results or consider retesting if clinically indicated. Siemens Healthcare Diagnostics is assisting customers with affected inventory.
The recalled product
- Product
- IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7,332
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- SMN 10706281: UDI - 00630414982212
- Lot Number D164
- SMN 10706282: UDI - 00630414982229
- Lot Number D166
- SMN 10380896 (OUS): UDI - 00630414961958
- SMN 10380996 (OUS): UDI - 00630414961965
- OUS Lot Numbers: 438
- 439
- 440
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Similar recalls
- HighSiemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues
FDA (Devices) · 2016-12-28
- HighSiemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure
FDA (Devices) · 2016-12-28
- HighSiemens Recalls IMMULITE PSA Kits Due to Negative Bias
FDA (Devices) · 2017-02-08
- HighSiemens IMMULITE PSA Kit Recall Due to Negative Bias Results
FDA (Devices) · 2017-02-08
- ModerateSiemens PSA Assay Kits Recalled for Positive Bias in Results
FDA (Devices) · 2013-09-04
- HighSiemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results
FDA (Devices) · 2017-03-15