Z-1365-2013Class II

MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory...

Name: Z-1365-2013 MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory...
Creator: Medical Information Technology, Inc.
Published: 2013-05-07
License: https://open.fda.gov/license/

Medical Information Technology, Inc. / initiated 2013-05-07 / Terminated / root cause: design

FDA source

Medical Information Technology, Inc. began a recall of MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems... on 2013-05-07. FDA classified it as Class II and gives the reason as "Incorrect transmission of laboratory results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1365-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-07
Posted: 2013-05-22
Terminated: 2014-10-01
Recalling firm: Medical Information Technology, Inc.
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.
Product code: OUG Medical Device Data System
Reason for recall: Incorrect transmission of laboratory results.
Root cause tag: design
FDA root cause: Device Design
Action: Beginning on May 7, 2013, MEDITECH distributed a notification to MAGIC and Client Server customers who have the MEDITECH Bi-Directional Interactive Communication Analyzer Interface in use with Vitros 3600, 4600, or 5600 Analyzer in TEST and/or LIVE. This notification was made via remailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. This notification informs customers of the potential patient safety issue that could result in reporting inaccurate qualitative results. Customers will receive a corrective change, in which the previous test's results will no longer be associated with the test not performed. Until customers receive the corrective change, they are instructed to monitor all No Result values from their analyzer and confirm that the result in MEDITECH matches. For further questions please call 781-821-3000, ext. 5742.
Quantity in commerce: 56 devices
Distribution: Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
Product codes and lots: Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1365-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1365-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)