FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: 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.
- Recall number
- Z-1914-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-05-03
- Posted
- not on file
- Terminated
- 2021-01-19
- Reason
- A steady upward trend in blank (u) absorbance was observed
- 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
- 899
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Serial Numbers: 280765, 280766, 280767
- 510(k) numbers
- ["K160724"]
- PMA numbers
- not on file
- Product code
- CGS
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28