SCC Soft Computer Recalls SoftLab Laboratory Information System Software
SCC Soft Computer is correcting SoftLab software versions that incorrectly displayed results from two different Sysmex hematology instruments under a single order.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported, fitting the criteria for minor labeling or functional errors.
Plain-English summary
SCC Soft Computer initiated a correction on October 17, 2011, for 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. The recall involves 88 units distributed nationwide in the United States.
The recall was initiated after a client reported an issue where results from two different sets of Sysmex series Hematology instruments were displayed under the same order on the instrument menu. SoftLab is a laboratory information system used in medical research or clinical laboratories by trained personnel to store, manage, query, and report laboratory data.
Users of the affected software versions should contact SCC Soft Computer for the correction. The source text does not specify specific consumer actions beyond the initiation of the correction by the manufacturer.
The recalled product
- Product
- 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…
- Manufacturer
- SCC Soft Computer
- Affected units
- 88
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · SCC Soft Computer
See all →- HighSCC Soft Computer Recalls SoftPath Laboratory Information System Versions
FDA (Devices) · 2015-02-18
- HighSCC Soft Computer Recalls SoftLab Laboratory Information System Versions
FDA (Devices) · 2015-02-11
- HighSCC Soft Computer Recalls SoftMic Laboratory Information System Software
FDA (Devices) · 2014-05-21
Same hazard · data integrity
See all →- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
Similar recalls
- HighSCC Soft Computer Recalls SoftLab Laboratory Information System Versions
FDA (Devices) · 2015-02-11
- HighSCC Soft Computer Recalls SoftPath Laboratory Information System Versions
FDA (Devices) · 2015-02-18
- HighSCC Soft Computer Recalls SoftMic Laboratory Information System Software
FDA (Devices) · 2014-05-21
- HighSoftLab Software Recalled for Incorrect Lab Result Display
FDA (Devices) · 2017-08-09
- HighSoftbank II Transfusion Software Recalled for Potential Incorrect Results
FDA (Devices) · 2017-02-01
- HighSoftCytogenetics Software Recalled for Incorrect Test Result Transmission
FDA (Devices) · 2021-07-28