CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Dimension Vista Enzymatic Creatinine (Ecrea) reagent, SMN recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine (Ecrea) reagent, SMN 10700444, distributed nationwide in the US. The recall was initiated on 18 Dec 2019 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-1233-2020
- FDA event ID
- 84612
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2019
- FDA classified
- 14 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Dec 2019 | Recall initiated by company | |
| 14 Feb 2020 | Classified by FDA | +58 days |
| 26 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Product as listed by the FDA
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Which lots are affected?
UDI Number: 00842768036262 Lots: All lots
Where was it sold?
US Nationwide
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 84612| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Dimension Enzymatic Creatinine (EZCR) reagent, SMN recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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