Siemens Recalls Dimension Vista Myoglobin Calibrator Due to Positive Result Shift
Siemens Healthcare Diagnostics is recalling Dimension Vista Myoglobin Calibrators because they may cause test results to shift up to 12% higher than expected.
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 illnesses. The hazard is a potential diagnostic error (positive shift) that may go undetected, fitting the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,230 units of the Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085. This in vitro diagnostic product is used to calibrate the Myoglobin (MYO) method on the Dimension Vista System. The affected units were distributed nationwide in the United States and in Canada.
The recall is being issued because the calibrator may produce a positive shift in Myoglobin quality control and patient test results that exceeds the product's acceptance criteria. The source text notes that a positive shift of up to 12% has been observed at Myoglobin concentrations within and above the reference range of the assay. Depending on the specific quality control limits used by a facility, this drift may not be detected.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,230
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 4FD085
- exp. 12-01-2014
Distribution
Distributed nationwide across the United States.
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