Siemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results
Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.
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, but the source text describes a specific complaint regarding inaccurate results without reporting hospitalizations, deaths, or significant injuries, fitting the criteria for a moderate severity recall involving potential diagnostic errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Protein 1 Calibrator (PROT 1 CAL) due to a complaint regarding high amounts of ceruloplasmin patient results falling below the reference range (< 20 mg/dL [0.2 g/L]). The issue stems from the PROT1 CAL and corresponding PROT1 CON L, M, and H being inaccurately assigned for ceruloplasmin (CER).
The affected product is an In Vitro Diagnostic (IVD) device. The recall covers specific lot numbers with expiration dates ranging from July 2017 to April 2018. The product was distributed nationwide in the United States and internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland, and the Republic of Korea South.
Healthcare facilities and laboratories should stop using the affected lots of the Dimension Vista Protein 1 Calibrator and contact Siemens Healthcare Diagnostics for further instructions on the recall.
The recalled product
- Product
- Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (20)
- Lot numbers: 6JC001
- 6JC001C
- 6JC001G (exp. date 2018-01-11)
- 6MC001
- 6MC001C (exp. date 2018-04-29)
- 6CC001A
- 6CC001B
- 6CC001F (exp. date 2017-07-14)
- 6FC001A
- 6FC001C
- 6FC001E (exp. 2017-10-27)
- --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714)
- 6CC001B (008427680244436CC001B20170714)
- 6CC001F (008427680244436CC001F20170714)
- 6FC001A (008427680244436FC001A20171027)
- 6FC001C (008427680244436FC001C20171027)
- 6FC001E (008427680244436FC001E20171027)
- 6JC001 (008427680244436JC00120180111)
- 6JC001C (008427680244436JC001C20180111)
- 6JC001G (008427680244436JC001G20180111)
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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