Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1231-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

Product Classification:

Class II

Date Initiated: December 18, 2019

Date Posted: February 26, 2020

Recall Number: Z-1231-2020

Event ID: 84612

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.

Status: Terminated

Product Quantity: 824 units

Code Information:

UDI Number: 00630414595795 Lots: All lots

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated