Misys Laboratory System Version 5.3
FDA device recall Z-0646-03 · posted 2003-03-13 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 465
- Distribution
- Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates,
- Date initiated
- 2003-02-06
- Date posted
- 2003-03-13
- Date terminated
- 2004-05-07
- Location
- Tucson, AZ
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