Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure
Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.
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: The recall involves a medical diagnostic device that fails to meet performance expectations, posing a risk of inaccurate results and potential harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay. The recall affects 4,705 kits, including 390 kits in the United States and 4,315 kits distributed worldwide. The specific lots involved are LKPS1/LKPS5 Lots 443, 445, and 446, and LKPTS1 Lot D116.
The recall was initiated because the assays are not meeting the current High-dose Hook Effect expectation outlined in the Instructions for Use. The product is an in vitro diagnostic (IVD) used with IMMULITE analyzers to measure PSA in human serum, serving as an aid in the detection and management of prostate cancer.
The affected products were distributed nationwide in the United States and in numerous countries worldwide. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (3)
- All lots LKPS1/LKPS5 - Lots 443
- 445
- 446 LKPTS1 - Lot D116
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →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
Same hazard · inaccurate diagnostic result
See all →- HighSiemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
FDA (Devices) · 2020-10-28
- ModerateBinding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
FDA (Devices) · 2020-03-18
- HighInstrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
FDA (Devices) · 2019-09-18
- HighHelena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
FDA (Devices) · 2019-07-17
- HighAbbott Recalls Architect Magnesium Assay Due to Depressed Urine Results
FDA (Devices) · 2019-03-13
Similar recalls
- HighIMMULITE 2000 PSA assay does not meet high-dose analytical performance claim
FDA (Devices) · 2024-11-20
- HighSiemens IMMULITE PSA Kit Recall Due to Negative Bias Results
FDA (Devices) · 2017-02-08
- HighSiemens Recalls IMMULITE PSA Kits Due to Negative Bias
FDA (Devices) · 2017-02-08
- ModerateSiemens PSA Assay Kits Recalled for Positive Bias in Results
FDA (Devices) · 2013-09-04
- ModerateSiemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure
FDA (Devices) · 2016-02-10
- HighSiemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference
FDA (Devices) · 2017-03-15