Recall Z-0444-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. SoftLab 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
| Date | Jan 11, 2012 (initiated Jul 26, 2011) |
| Status | Terminated |
| Reason | SCC Soft Computer, Clearwater, FL, initiated a correction for the SoftLab used with SA INST. A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database. |
| Root cause | Software design |
| Action | The firm, SCC Soft Computer, sent a "Correction Communication" letter on July 26, 2011 to customers/consignees. The letter describes the product problem and actions to be taken. The firm will correct the software to recognize and support all known formats of the resulting date and time sent by an instrument. The software is available via a recommended patch or hot fix to the client's current release. The customers were asked to acknowledge receipt of the task and grant permission for SCC to correct the affected configuration files. If you have any questions, call (727) 789-0100. |
| Quantity | 265 |
| Distribution | Worldwide Distribution - USA (Nationwide) and Country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.