FDA recall Z-2650-2017

Product

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

Reason for recall

Linear performance information in product insert does not match that listed in the approved premarket notification

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2011-10-19

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-2650-2017