Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
FDA Recall Z-1231-2020 · Posted 2020-01-24
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJFY
Date Initiated2019-12-18
Date Terminated2020-06-25
Product Quantity824 units
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.
Firm Action
Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.