medical Class II Updated 2018-10-24

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

Distribution: Nationwide (United States)
Lot/Code Info: SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210
View official government recall

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