Chemistry Calibrator Set
CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model 10 x 5mL, 1 x 50mL · UDI-DI 00812137012111
Description
The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-01 | Aniara Diagnostica LLC | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | 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 failur |
| 2024-03-05 | Randox Laboratories Ltd. | Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to o |
| 2024-03-01 | Randox Laboratories Ltd. | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. |
| 2023-11-20 | Randox Laboratories Ltd. | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient |
| 2023-11-20 | Randox Laboratories Ltd. | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patie |
| 2023-11-13 | Randox Laboratories Ltd. | There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and T |
| 2023-10-26 | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due |
| 2023-10-26 | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due |
| 2023-10-26 | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due |
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