FDAFDA · Food and drugs·Recall number Z-1233-2020
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Published February 26, 2020 · Recall initiated: December 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- US Nationwide
- Lot
- UDI Number: 00842768036262 Lots: All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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