FDA recall Z-2649-2017

Product

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

Reason for recall

Incorrect control range in product labeling

Distribution

FL, AR, NICARAGUA, KOREA

Key facts

Status

Terminated

Initiation date

2010-11-22

Report date

2017-07-05

Termination date

2017-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canton, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2017