Z-2628-2017Class II

Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for...

Name: Z-2628-2017 Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for...
Creator: Merge Healthcare, Inc.
Published: 2016-04-15
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-15 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s... on 2016-04-15. FDA classified it as Class II and gives the reason as "There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2628-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2017-05-25
Terminated: 2019-03-13
Recalling firm: Merge Healthcare Incorporated
Product: Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
Root cause tag: software
FDA root cause: Software design
Action: Merge Healthcare issued a letter dated April 15, 2017, via email or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround, and lets them know a fix is being planned and they will be notified once it is made available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 29, 2016. For further questions, call (877) 741-5369.
Quantity in commerce: 638 sites have the potentially affected versions
Distribution: Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.
Product codes and lots: Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2628-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2628-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23

Product code JQP

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)