Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery
Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic errors (discrepant low calcium recovery) which poses a risk of harm to patients through inaccurate medical decisions, though no specific injuries are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 9,935 units of the Dimension Vista Chemistry 1 Calibrator (KC110B). The affected lots are 5GM081 and 5GM082. This in vitro diagnostic product is used to calibrate various chemistry methods, including Calcium, on the Dimension Vista System.
The recall was initiated because Siemens determined that discrepant low calcium recovery of quality control and patient samples can occur with these specific lots. This issue may affect the accuracy of calcium test results.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users of the Dimension Vista System should check their inventory for these specific lot numbers and follow instructions from Siemens or their local regulatory authority regarding the return or replacement of the product.
The recalled product
- Product
- Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU)…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 9,935
Distribution
Distributed nationwide across the United States.
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