CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report
SoftLab with SA INST versions recalled by SCC Soft Computer
SCC Soft Computer is recalling SoftLab with SA INST versions: 1.6.12, 0.1.26-4.0.1.32, 0.2.21-4.0.2.51, and, distributed nationwide in the US. The recall was initiated on 17 Oct 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2143-2012
- FDA event ID
- 62023
- Recalling firm
- SCC Soft Computer, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2011
- FDA classified
- 3 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 17 Oct 2011 | Recall initiated by company | |
| 3 Aug 2012 | Classified by FDA | +291 days |
| 15 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is SoftLab with SA INST versions: 1.6.12, 0.1.26-4.0.1.32, 0.2.21-4.0.2.51, and recalled?
Yes. SCC Soft Computer recalled SoftLab with SA INST versions: 1.6.12, 0.1.26-4.0.1.32, 0.2.21-4.0.2.51, and on 17 Oct 2011. The recall is Class II and its status is Terminated. Recall number Z-2143-2012.
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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