FDA recall Z-0117-2019

Product

Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

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-0117-2019