FDA Device recall Z-2437-2020

(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System…

• FDA Device
• Class II
• terminated
• Published 2020-07-08

On 2020-07-08 the FDA classified a Class II recall of (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System… by Siemens Healthcare Diagnostics, citing 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 f….

Read the official FDA Device notice

Product

(1) 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.

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2437-2020%22

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