Agency classClass IIOur severity:High FDA (Devices)·Z-0175-2018·Announced 2017-12-06

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.

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 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.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
inaccurate-results

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.

See all 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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