# FDA recall Z-2865-2017

> **Soft Computer Consultants, Inc.** · Class II · device recall initiated 2017-05-31.

## Product

SoftLab Software    Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

## Reason for recall

Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.

## Distribution

US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

## Key facts

- **Recall number:** Z-2865-2017
- **Recalling firm:** Soft Computer Consultants, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-31
- **Report date:** 2017-08-09
- **Termination date:** 2020-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clearwater, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2865-2017

## Citation

> AI Analytics. FDA recall Z-2865-2017. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-2865-2017. Source: US FDA. Licensed CC0.

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