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Recall Observatory FDA recall evidence

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.