medical Class II Updated 2018-10-24

Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768

Recalled Product

ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 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 10309782 Lot # Expiry UDI # 35061 2019-02-10 (01)00630414056098(10)35061(17)20190210 39753 2020-06-11 (01)00630414056098(10)39753(17)20200611
View official government recall

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