Z-1234-2014Class II
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14...
Medical Information Technology, Inc. / initiated 2014-02-21 / Terminated / root cause: design
Medical Information Technology, Inc. began a recall of MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and... on . FDA classified it as Class II and gives the reason as "Potential for erroneous result reporting". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1234-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medical Information Technology, Inc.
- Product
- MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
- Product code
- JQP Calculator/Data Processing Module, For Clinical Use
- Reason for recall
- Potential for erroneous result reporting.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Beginning on February 3, 2014 MEDITECH distributed a notification to Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. The issue will be corrected by CS LAB DTS 12279.
- Quantity in commerce
- 438
- Distribution
- Distributed USA (nationwide) and Canada.
- Product codes and lots
- Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1234-2014 | Class II | Terminated | Voluntary: Firm initiated |
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