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Synermed®
INFRARED LABORATORY SYSTEMS LLC · Model IR170-WK · UDI-DI 05060500091187
JGJ
Prescription
1
510(k) clearances
370
Adverse events
13
Recalls
43
Facilities
Description
Magnesium Reagent 2 X 55 mL
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 potential for false |
| 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 always detected by QC an |
| 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 for QC failures or |
| 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 30.38% in low magne |
| 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 linearity acceptance criter |
| 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 required to the RX Imol |
| 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 results. The under- |
| 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 Magnesium RTU package in |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.