Siemens Healthcare Diagnostics, Inc recalls Atellica IM CKMB Master Curve Material, Cat No. 10995534
Recalled 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.
Hazard / Issue
A potential bias was identified with certain kits compared to the internal standards.
Issued by
FDA
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