Reported Apr 24, 2019 · Terminated
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- syngo
- Lab Data Manager System - Product Usagesyngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features
- Lot codes and dates
- Catalog Numbers
106389331062407710804573 510K Exempt
- Catalog Numbers
- Amount recalled
- 449 systems
Where it was sold
- Nationwide
Why it was recalled
Software Issues.
This product could cause temporary or reversible health problems — stop using it.
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