Recall Z-2098-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Soft Computer Consultants, Inc.
SoftCytogenetics
| Date | Mar 31, 2021 |
| Status | Terminated |
| Reason | Software is given wrong results going out to HIS on test that had reruns. |
| Root cause | Software design (manufacturing process) |
| Action | Dear SoftCytogentics Customer, The purpose of this letter is to advise you that SCC is voluntarily recalling SoftCytogenetics 4.1.11.20 and 4.1.12.11. There are software errors in these versions which SCC has designated to pose a potential risk-to-health issue. Reason for the Voluntary Recall: This task is to inform you of functionality in SoftCytogentics which SCC has designated to be a potential patient Risk-to-Health issue. For clients using Outbound Result Reporting with Resulting Profiles including Test Chapter macros, for cases that had multiple runs for reportable fields included to the |
| Quantity | 5 |
| Distribution | US Nationwide Distribution in the states of CA, FL, MN and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.