FDA recall Z-0113-2019

Siemens Healthcare Diagnostics, Inc · Class II · device

Product

ADVIA Centaur CKMB Calibrator, Cat No. 09318028 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-0113-2019