CLASS II Device recall · Reported 6 Dec 2017 · FDA Enforcement Report
Dimension Vista Protein 1 Control M, PROT 1 CON M recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, distributed nationwide in the US. The recall was initiated on 23 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0175-2018
- FDA event ID
- 77381
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2017
- FDA classified
- 28 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 23 May 2017 | Recall initiated by company | |
| 28 Nov 2017 | Classified by FDA | +189 days |
| 6 Dec 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
Product as listed by the FDA
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Where it was distributed
Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
Questions about this recall
Why was it recalled?
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
Which lots are affected?
Lot numbers: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) --- Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131), 6BQM01A (008427680063406BQM01A20170617), 6BQM01B (008427680063406BQM01B20170617), 6BQM01C (008427680063406BQM01C20170617), 6BQM01D( 008427680063406BQM01D20170617), 6BQM01E (008427680063406BQM01E20170617), 6FQM01(008427680063406FQM0120171103), 6FQM01A (008427680063406FQM01A20171103).
Where was it sold?
Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 77381| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dimension Vista Protein 1 Control H, PROT 1 CON H recalled | Siemens Healthcare Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Dimension Vista Protein 1 Calibrator, PROT 1 CAL recalled | Siemens Healthcare Diagnostics | Labeling Errors | Nationwide | |
| CLASS II | Dimension Vista Protein 1 Control, PROT 1 CON L recalled | Siemens Healthcare Diagnostics | Labeling Errors | Nationwide |
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