Siemens Dimension Vista Protein 1 Control H Recalled for Inaccurate Ceruloplasmin Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control H due to inaccurate ceruloplasmin test results.
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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source describes a specific complaint regarding inaccurate test results but does not report hospitalizations, deaths, or serious injuries, fitting the Moderate severity criteria for a Class II recall without severe reported outcomes.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Protein 1 Control H (Siemens Material Number 10445921, Product Code KC717). This is an in vitro diagnostic (IVD) product used for laboratory testing.
The recall was initiated because of a complaint regarding high amounts of ceruloplasmin in patient results that fell below the reference range (< 20 mg/dL [0.2 g/L]). The source text indicates that the PROT1 CAL and corresponding PROT1 CON L, M, and H products were inaccurately assigned for ceruloplasmin (CER).
The affected lots are 6EQH01, 6EQH01A, 6EQH01B, and 6EQH01C (expiration date 2017-09-17) and 6LQH01A, 6LQH01B, and 6LQH01C (expiration date 2018-04-04). The product was distributed nationwide in the US and internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland, and the Republic of Korea South. Users should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (12)
- Lot numbers: 6EQH01
- 6EQH01A
- 6EQH01B
- 6EQH01C (exp. date 2017-09-17)
- 6LQH01A
- 6LQH01B
- 6EQH01A (008427680063576EQH01A2017091)
- 6EQH01B(008427680063576EQH01B20170917)
- 6EQH01C(008427680063576EQH01C20170917)
- 6LQH01A (008427680063576LQH01A20180404)
- 6LQH01B (008427680063576LQH01B20180404)
- 6LQH01C (008427680063576LQH01C20180404).
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.
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