Azo Dye, Calcium

VITROS Chemistry Products Ca Slides;

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use.

High positive calcium bias on plasma sample versus results on serum

Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use

High positive calcium bias on plasma sample versus results on serum

VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum.

Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.

Randox CALCIUM (Ca) Colorimetric Method RX Series

Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

Randox CALCIUM (Ca) COLORIMETRIC METHOD

Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 sl

Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.