Z-1231-2020Class II

Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533

Name: Z-1231-2020 Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-12-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-12-18 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 on 2019-12-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1231-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-18
Posted: 2020-01-24
Terminated: 2020-06-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Product code: JFY Enzymatic Method, Creatinine
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.
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019.
Quantity in commerce: 824 units
Distribution: US Nationwide
Product codes and lots: UDI Number: 00630414595795 Lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1231-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1230-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1231-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1232-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14
Z-1233-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-14

Product code JFY

K070727Class IIAdvia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics / cleared 2007-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)