The Recall Desk
ModerateFDA (Devices)·Z-2143-2012·Announced 2012-08-15

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.

What this means for you

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
Category
Medical Device — Laboratory Software
Hazard
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.

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