Recall Z-0646-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory System Version 5.3
| Date | Mar 13, 2003 (initiated Feb 6, 2003) |
| Status | Terminated |
| Reason | Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery. |
| Root cause | Other |
| Action | Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003 |
| Quantity | 465 |
| Distribution | Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.