Home › Device types › JIX
Calibrator, Multi-Analyte Mixture
FDA product code JIX · Class 2 · Clinical Chemistry
695
Registered devices
582
Adverse events
73
Recalls
302
510(k) clearances
Devices with this code
Atellica CH ENZ 1 Calibrator — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHBioPlex 2200 — BIO-RAD LABORATORIES, INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONQUANTA Flash® DGP Screen Calibrators — INOVA DIAGNOSTICS, INC.Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.AU — BECKMAN COULTER IRELAND INC.CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.QUANTA Flash® Centromere Calibrators — INOVA DIAGNOSTICS, INC.Serum Calibrator Set — Chromsystems Instruments + Chemicals GmbHBioPlex 2200 — BIO-RAD LABORATORIES, INC.RAPIDPoint® 500 Measurement Cartridge — Siemens Healthcare Diagnostics Inc.Plasma Calibrator Set — Chromsystems Instruments + Chemicals GmbHTeco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSN Protein Standard UY — Siemens Healthcare Diagnostics Products GmbHSynermed® — INFRARED LABORATORY SYSTEMS LLCSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSCAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 1 CC908 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAtellica A-LYTE IMT Standard A — Siemens Healthcare Diagnostics Inc.Plasma Calibrator Set — Chromsystems Instruments + Chemicals GmbHSEEKER® — Lacar MDX Technologies
Recent 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 me |
| 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 con |
| 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 instr |
| 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 |
| 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 Quali |
| 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 value |
| 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 |
| 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 |
| 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 |
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