Recall Z-0939-05 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Mysis Laboratory version 6.1
| Date | Jun 28, 2005 (initiated May 10, 2005) |
| Status | Terminated |
| Reason | When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted. |
| Root cause | Other |
| Action | Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw. |
| Quantity | 21 |
| Distribution | Nationwide and United Kingdom and Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.