Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1269-2023·Announced 2023-09-06

Siemens Atellica CH Total Protein II Recalled for Reagent Carryover

Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.

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 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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a technical quality issue (reagent carryover affecting test accuracy) being addressed through a precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Total Protein II diagnostic reagent due to reagent carryover that impacts magnesium test results. Carryover from other assays performed on the Atellica CH Analyzer—including LDL Cholesterol Direct, Total Protein II, Triglycerides, and Triglycerides_2—can contaminate samples and affect magnesium result accuracy.

Approximately 13,071 units are affected by this recall, distributed nationwide and in multiple countries worldwide. The Atellica CH Total Protein II is an in vitro diagnostic used in clinical laboratory settings to quantify total protein in human serum and plasma samples.

Laboratory professionals and healthcare facility administrators should contact Siemens Healthcare Diagnostics for recall guidance. The affected reagents are identified by UDI 00630414596372, which covers all lot numbers. Users should follow the manufacturer's instructions regarding this recall.

This FDA Class II recall has been issued to address the identified quality control issue that could compromise diagnostic accuracy if not corrected.

The recalled product

Product: Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Laboratory Diagnostic Reagent
Hazard: reagent-carryover
inaccurate-results
Affected units: 13,071

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)

UDI: 00630414596372 All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · reagent carryover