—#178848

Product

ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869

FDA product code: JFY — Enzymatic Method, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K070727
Affected lot / code info: UDI Number: 00630414526690 Lots: All lots

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2019-12-18
Posted by FDA: 2020-01-24
Terminated: 2020-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.