Siemens Healthcare Diagnostics, Inc recalls Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centa…

Recall date

July 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0116-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atellica IM CKMB Calibrator, Cat No. 10995532 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.