—#173277

Product

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - 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.

FDA product code: CGS — Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K160724
Affected lot / code info: Serial Numbers: 465336,465663,468449

Why it was recalled

A steady upward trend in blank (u) absorbance was observed

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2019-05-03
Terminated: 2021-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.