Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
FDA device recall Z-0238-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.
- Action taken
- A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 125
- Distribution
- Nationwide, Canada, Saudi Arabia, United Kingdom.
- Date initiated
- 2003-07-21
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-15
- Location
- Tucson, AZ
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