Device product

ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

Z-0113-2019

July 24, 2018

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 80954
Status: Terminated
Classification: Class II
Quantity: 1870 kits
Official record key: device-enforcement:Z-0113-2019

Official wording

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

Code information: SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211

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.