Device product

ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

Z-0114-2019

July 24, 2018

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 80954
Status: Terminated
Classification: Class II
Quantity: 69 kits
Official record key: device-enforcement:Z-0114-2019

Official wording

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

Code information: SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(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.