Reported Aug 15, 2012 · Terminated
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product…
SCC Soft Computer
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: SCC Soft Computer · 5400 Tech Data Drive · Clearwater, FL · 33760
Is this the product you have?
- SoftLab with SA INST versions3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data
- Lot codes and dates
- SA INST versions
3.1.6.124.0.1.26-4.0.1.324.0.2.21-4.0.2.51and 4.0.3.5-4.0.3.13
- SA INST versions
- Amount recalled
- 88
Where it was sold
- Nationwide
Why it was recalled
On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu.
This product could cause temporary or reversible health problems — stop using it.
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