Siemens Dimension Vista CHEM 1 CAL Recall for Magnesium Calibration Error
Siemens is recalling Dimension Vista CHEM 1 CAL lot 3GM081 because it causes under-recovery of Magnesium in patient and QC samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a diagnostic accuracy issue without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista CHEM 1 CAL, lot 3GM081. This in vitro diagnostic product is used for the calibration of various methods, including Magnesium (MG), on the Dimension Vista System. The recall involves 9,769 total units, with 6,000 distributed in the United States and the remainder distributed internationally to countries including Australia, Austria, Belgium, Canada, and others.
The recall was initiated after Siemens received complaints regarding low recovery of Magnesium in Quality Control (QC) and patient samples following calibration with the affected lot. An investigation by Siemens confirmed that the product causes QC and patient samples to under-recover Magnesium by 0.25 mg/dL [0.10 mmol/L] across the assay range.
Healthcare facilities and laboratories that have used or possess this specific lot of the calibration product should stop using it and contact Siemens Healthcare Diagnostics for instructions on return or replacement. The affected lot has an expiration date of 07-01-2014.
The recalled product
- Product
- Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitr
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- lot 3GM081
- exp. 07-01-2014
Distribution
Distributed nationwide across the United States.
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