Home › Device types › JGJ
Photometric Method, Magnesium
FDA product code JGJ · Class 1 · Clinical Chemistry
70
Registered devices
370
Adverse events
13
Recalls
90
510(k) clearances
Devices with this code
Pointe Scientific, Inc. Magnesium — HORIBA INSTRUMENTS INCORPORATEDARCHITECT — ABBOTT LABORATORIESPointe Scientific, Inc. Magnesium — HORIBA INSTRUMENTS INCORPORATEDMagnesium Assay — Sekisui Diagnostics, LLCMagnesium Gen.2 — Roche Diagnostics GmbHARCHITECT — ABBOTT IRELANDYumizen C1200 Magnesium — HORIBA ABX SASPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCCAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT ST220 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific, Inc. Magnesium Std — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCTeco Diagnostics Magnesium Reagent Set — TECO DIAGNOSTICSMAGNESIUM (Mg) — RANDOX LABORATORIES LIMITEDMAGNESIUM Reagent — Sekisui Diagnostics, LLCARCHITECT — Abbott GmbHPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDAlinity — ABBOTT IRELANDCAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220 — CAROLINA LIQUID CHEMISTRIES CORPORATIONMedTest DX Magnesium on the BS200 — Medtest Dx, Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ARCHITECT — Abbott GmbHSPOTCHEM™ II Magnesium — ARKRAY USA, INC.MedTest DX Magnesium for the BS480 — Medtest Dx, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-12 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the |
| 2022-08-17 | Siemens Healthcare Diagnostics, Inc. | Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not alwa |
| 2022-01-28 | Siemens Healthcare Diagnostics, Inc. | Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential |
| 2021-12-08 | Beckman Coulter Inc. | Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to |
| 2020-11-13 | Randox Laboratories Ltd. | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine |
| 2020-11-13 | Randox Laboratories Ltd. | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine |
| 2019-01-02 | Abbott Laboratories, Inc | Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the lineari |
| 2016-04-14 | Randox Laboratories, Limited | According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is req |
| 2015-09-30 | Siemens Healthcare Diagnostics, Inc. | Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample |
| 2014-08-11 | Horiba Instruments, Inc dba Horiba Medical | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magn |
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