System, Test, Low Density, Lipoprotein

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using th

Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

LDL-Cholesterol gen.2.

Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN

The expiration date was extended by 20 weeks without justification.

Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322.

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent

LDL Cholesterol component in controls are unstable.

LDL Cholesterol Reagent (LDLD)

Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC)

VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

Advia Chemistry Assay: LDL Cholesterol, Direct

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific