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Recall Observatory FDA recall evidence

Device 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).

Z-1234-2014

February 21, 2014

Class II

Product summary

Firm
Medical Information Technology, Inc.
Event
Event 67584
Status
Terminated
Classification
Class II
Quantity
438
Official record key
device-enforcement:Z-1234-2014

Official wording

Reason: Potential for erroneous result reporting.

Code information: Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.

Distribution pattern: Distributed USA (nationwide) and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for erroneous result reporting.