Siemens Dimension Vista Protein 1 Control M Recalled for Inaccurate Ceruloplasmin Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M units because they may produce inaccurate ceruloplasmin results below the reference range.
What this means for you
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 diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Protein 1 Control M (SMN 10445920, Product Code KC716) in the United States and internationally. The recall involves specific lots with expiration dates of June 17, 2017, and November 3, 2017. The product is an in vitro diagnostic (IVD) control material used in laboratory testing.
The recall was initiated due to a complaint that the control material inaccurately assigned ceruloplasmin (CER) values, resulting in patient results below the reference range (< 20 mg/dL [0.2 g/L]). The issue affects the PROT1 CAL and corresponding PROT1 CON L, M, and H components.
Healthcare facilities and laboratories that have received these specific lots should stop using the affected control material and contact Siemens Healthcare Diagnostics for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; 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: 6BQM01
- 6BQM01A
- 6BQM01B
- 6BQM01C
- 6BQM01D
- 6BQM01E (exp. date 2017-06-17)
- 6FQM01
- 6BQM01A (008427680063406BQM01A20170617)
- 6BQM01B (008427680063406BQM01B20170617)
- 6BQM01C (008427680063406BQM01C20170617)
- 6BQM01D( 008427680063406BQM01D20170617)
- 6BQM01E (008427680063406BQM01E20170617)
- 6FQM01(008427680063406FQM0120171103)
- 6FQM01A (008427680063406FQM01A20171103).
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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