Siemens ADVIA Centaur CKMB Master Curve Material Recalled for Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential bias without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 379 sets of ADVIA Centaur CKMB Master Curve Material, Catalog Number 07867768. This product is used for in vitro diagnostic purposes to evaluate the ADVIA Centaur CKMB assay. The recall covers lots 35061 and 39753, which were distributed nationwide in the United States.
The recall was initiated because a potential bias was identified with certain kits when compared to the internal standards. This issue may affect the accuracy of the diagnostic evaluations performed using the affected material.
Healthcare facilities and laboratories that have purchased or received this product should stop using the affected lots immediately. Siemens Healthcare Diagnostics, Inc. is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 379
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 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 · diagnostic inaccuracy
See all →- High
- HighAtellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
FDA (Devices) · 2026-07-15
- HighTBS iNsight bone density software calculation variability on Hologic machines
FDA (Devices) · 2025-03-12
- HighBD PCR Cartridges for MAX System signal drift in select lots
FDA (Devices) · 2025-01-29
- HighHPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization
FDA (Devices) · 2024-12-04
Similar recalls
- ModerateSiemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias
FDA (Devices) · 2019-05-08
- ModerateSiemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
FDA (Devices) · 2017-03-08
- ModerateSiemens ADVIA Centaur BR Assay Recalled for Quality Control Issues
FDA (Devices) · 2012-11-07
- HighSiemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias
FDA (Devices) · 2023-05-10
- LowSiemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure
FDA (Devices) · 2012-09-26
- ModerateSiemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias
FDA (Devices) · 2013-04-24