Device 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.

Z-0115-2019

July 24, 2018

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 80954
Status: Terminated
Classification: Class II
Quantity: 379 sets
Official record key: device-enforcement:Z-0115-2019

Official wording

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

Code information: 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

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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