Data Foundry

Medical device recalls 2013

MEDITECH Bi-Directional interactive Communication Analyzer Interface — Class II medical device recall Z-1365-2013

Terminated recall by Medical Information Technology, Inc., reported 2013-05-29, distributed in PR. Incorrect transmission of laboratory results.

Recall numberZ-1365-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedical Information Technology, Inc., Westwood, MA, United States
Recall initiated2013-05-07
Classified2013-05-22
Reported by FDA2013-05-29
Terminated2014-10-01
DistributedPR
Countries outside the USCA
Quantity56 devices

Product

MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.

Reason for recall

Incorrect transmission of laboratory results.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1365-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.