Device product

Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

Z-1233-2020

December 18, 2019

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 84612
Status: Terminated
Classification: Class II
Quantity: 11,725 units
Official record key: device-enforcement:Z-1233-2020

Official wording

Reason: 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.

Code information: UDI Number: 00842768036262 Lots: All lots

Distribution pattern: US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.