Recall Z-0678-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Misys Healthcare Systems
Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
| Date | Mar 26, 2003 (initiated Jan 17, 2003) |
| Status | Terminated |
| Reason | Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol. |
| Root cause | Other |
| Action | Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready. |
| Quantity | 520 |
| Distribution | Nationwide and to United Kingdom, Ireland, Canada, Denmark, 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.