Siemens Dimension Vista Alkaline Phosphatase Calibrator Recalled for Accuracy Shift
Siemens Healthcare Diagnostics is recalling 1,985 cartons of Dimension Vista Alkaline Phosphatase Calibrators due to correlation slope bias and accuracy shift.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the criteria for a Low severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,985 cartons of the Siemens Dimension Vista Alkaline Phosphatase (ALP) Calibrator. The product is an in vitro diagnostic used to calibrate the Alkaline Phosphatase method on the Dimension Vista System. The recall is being conducted because the product exhibits correlation slope bias and accuracy shift.
The affected product is identified by Lot 2AD052 and Catalog KC330. The recall covers nationwide distribution in the United States, including Puerto Rico and specific states such as Alabama, Ohio, Missouri, Georgia, Illinois, Connecticut, Iowa, South Carolina, Virginia, Texas, Florida, New York, North Carolina, California, New Mexico, Arizona, Michigan, New Jersey, Mississippi, Nebraska, West Virginia, Pennsylvania, Montana, Massachusetts, Maryland, Kansas, New Hampshire, Tennessee, Vermont, Louisiana, Colorado, Idaho, Washington, Delaware, and Oregon.
Consumers and healthcare facilities should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for further instructions or a replacement. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,985
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 (1)
- Lot 2AD052 Catolog KC330
Distribution
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