Z-0193-2022 Class II Ongoing

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

Recall Details

Product Type
Devices
Report Date
November 10, 2021
Initiation Date
October 6, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1142

Product Description

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

Reason for Recall

The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

Distribution Pattern

Worldwide distribution.

Code Information

UDI 00630414596754