Siemens Healthcare Diagnostics, Inc. Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI Number: 00842768036262 Lots: All lots
Products Sold
UDI Number: 00842768036262 Lots: All lots
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 due to There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference h. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026