Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1217-2017·Announced 2017-02-22

Siemens Enzyme II Calibrator Recalled for ALTI Result Shifts

Siemens Healthcare Diagnostics is recalling Enzyme II Calibrators because they may cause patient and QC results to shift by up to 10% on the Dimension clinical chemistry system.

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 2/5 (Moderate).

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 III, which is defined as unlikely to cause adverse health consequences. The issue involves a 10% shift in diagnostic results, which is a functional defect rather than a direct physical hazard like injury or death.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 24,940 units of the Enzyme II Calibrator, an in vitro diagnostic product used for the Alanine Aminotransferase (ALTI) assay on the Dimension clinical chemistry system. The product is for prescription use only and was distributed throughout the United States.

The recall was initiated after complaints indicated a positive shift in patient and quality control (QC) results when the ALTI assay was calibrated with the Dimension Enzyme II calibrator. An internal investigation confirmed that patient samples and QC material demonstrated a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

Affected lots include 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, and 6AD054. Healthcare facilities and laboratories should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for further instructions.

The recalled product

Product: The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results

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 (8)

Product Lot: 4MD047
5CD052
5FD017
5GD050
5HD010
5JD069
5LD051
6AD054

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.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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