Siemens Enzyme 2 Calibrator Recalled for Positive Result Shifts
Siemens Healthcare Diagnostics is recalling Enzyme 2 Calibrators because they may cause patient and QC results to shift up to 10% when used with the Dimension Vista System.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation unlikely to cause adverse health consequences. The issue is a calibration shift rather than a direct physical hazard or contamination.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 13,147 units of the Enzyme 2 Calibrator, an in vitro diagnostic product used for the calibration of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. The affected lots are 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, and 5LD061. These products were distributed throughout the United States.
The recall was initiated due to complaints of a positive shift in patient and quality control (QC) results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. An internal investigation confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
This product is for prescription use only. Healthcare facilities and laboratories should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for instructions on returning the product.
The recalled product
- Product
- The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 13,147
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 (6)
- Lot Number: 4MD048
- 5DD026
- 5ED071
- 5GD004
- 5JD058
- 5LD061
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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