Recall Z-1231-2020— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1231-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-18

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2019-12-18, terminated 2020-06-25. It names one FDA 510(k) clearance: K070727. Product: Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-18
Terminated: 2020-06-25
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2Siemens Medical Solutions Diagnostics·cleared 2007-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.