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.

There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.

Recall #: Z-2628-2017
Affected scope: 638 sites have the potentially affected versions
Initiated: April 15, 2016

Compiled from official public sources by the publisher. · Updated September 2026

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Merge Healthcare, Inc. recalled Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system … - a moderate-severity action.

Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system … was recalled by Merge Healthcare, Inc. in July 5, 2017. Reason: There are potential issues with results reporting for certain run-based tests. Under certain conditions, the…. Check the official notice for the remedy. Verify recall #Z-2628-2017 with the FDA Devices before acting.

The recall

Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-There are potential issues with results reporting for certain run-based tests. Under certain conditions, the….

Moderate
severity level: Class II
classification: July 5, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2628-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2628-2017
Date reported	July 5, 2017
Date initiated	April 15, 2016
Recalling firm	Merge Healthcare, Inc.
Firm location	Hartland, WI
Affected scope	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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2628-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 5, 2017. Severity: Moderate. Recall number: Z-2628-2017.

Where was the recalled product distributed? ▼

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..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported July 5, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026