Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 7/8/2020
Class II
PRODUCT
CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.
Recall Number: Z-2437-2020
REASON
Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. on 7/20/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
186 units
DISTRIBUTION
International