Siemens Dimension Vista Protein 1 Control Recalled for Inaccurate Ceruloplasmin Assignment
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control lots due to inaccurate ceruloplasmin assignment, which may cause patient results to fall 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (inaccurate patient results) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of Dimension Vista Protein 1 Control (SMN 10445919, Product Code KC715). The recall affects lots 6BQL01, 6BQL01A, 6BQL01B, 6BQL01C, 6BQL01D, 6JQL01A, 6JQL01B, and 6JQL01C. These products were 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.
The recall was initiated because the Dimension Vista Protein 1 Control and corresponding calibration materials were inaccurately assigned for ceruloplasmin (CER). This error resulted in patient ceruloplasmin results being reported below the reference range (< 20 mg/dL [0.2 g/L]).
Healthcare facilities and laboratories that possess the affected lots should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; 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 (14)
- Lot numbers: 6BQL01
- 6BQL01A
- 6BQL01B
- 6BQL01C
- 6BQL01D (exp. date 2017-06-13)
- 6JQL01A
- 6JQL01B
- 6BQL01A (008427680063406BQM01A20170617)
- 6BQL01B (008427680063406BQM01B20170617)
- 6BQL01C (008427680063406BQM01C20170617)
- 6BQL01D (008427680063406BQM01D20170617)
- 6JQL01A (008427680063336JQL01A20180131)
- 6JQL01B (008427680063336JQL01B20180131)
- 6JQL01C (008427680063336JQL01C20180131).
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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