# FDA recall Z-2437-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-05-15.

## 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 for recall

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

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas,   Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait,   Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2437-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-15
- **Report date:** 2020-07-08
- **Termination date:** 2021-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2020

## Citation

> AI Analytics. FDA recall Z-2437-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2437-2020. Source: US FDA. Licensed CC0.

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