FDA recall Z-1913-2019

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.

Reason for recall

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

Distribution

Worldwide distribution.

Key facts

Status

Terminated

Initiation date

2019-05-03

Report date

2019-07-10

Termination date

2021-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2019