FDA recall Z-0114-2019

Product

ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

Reason for recall

A potential bias was identified with certain kits compared to the internal standards.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-07-24

Report date

2018-10-24

Termination date

2020-05-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Walpole, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2019