Device product

Atellica IM CKMB Calibrator, Cat No. 10995532 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-0116-2019

July 24, 2018

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 80954
Status: Terminated
Classification: Class II
Quantity: 97 kits
Official record key: device-enforcement:Z-0116-2019

Official wording

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

Code information: SMN 10995532 Lot # Expiry UDI # 57837A66 2018-12-11 (01)00630414598598(10)57837A66(17)20181211 67443A66 2018-12-11 (01)00630414598598(10)67443A66(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.