Z-1914-2019Class II

Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 -

Name: Z-1914-2019 Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-05-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-05-03 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay... on 2019-05-03. FDA classified it as Class II and gives the reason as "A steady upward trend in blank (u) absorbance was observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1914-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Posted: 2019-07-02
Terminated: 2021-01-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
Product code: CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Reason for recall: A steady upward trend in blank (u) absorbance was observed
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthineers issued Urgent Medical Device Recall notices to domestic customers and Urgent Field Safety Notices to international customers dated May 8, 2019. Actions to be Taken by the Customer 1) Discontinue use of and discard the kit lots listed on the notice. 2) Review your inventory of these products to determine your laboratorys replacement needs and provide information to Siemens for reporting to the authorities. 3) Complete and return the Field Correction Effectiveness Check letter within 30 days. 4) Please review the letter with your Medical Director. 5) If you have received any complaints of illness or adverse events associated with the products listed in the notice, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. 6) Please retain the letter with your laboratory records and forward the letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 899
Distribution: Worldwide distribution.
Product codes and lots: Serial Numbers: 280765, 280766, 280767

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1914-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1913-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1914-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02

Product code CGS

K160724Class IIADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2016-09-07

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)