Recall Z-1573-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying
| Date | May 9, 2014 (initiated Jan 29, 2014) |
| Status | Terminated |
| Reason | When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates. |
| Root cause | Software design |
| Action | On 2/10/2014 SCC Soft Computer used a proprietary task management system to send a Correction Communication to the consignee with the affected software. The letter identifies the product, problem and corrective actions. |
| Quantity | 1 |
| Distribution | Distributed in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.