Reported Jul 9, 2014 · Terminated
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
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 ManagerSMN 1080005710803189and 10804573
- Lot codes and dates
- syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
- Amount recalled
- 336
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
This product could cause temporary or reversible health problems — stop using it.
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