Agency classClass IIOur severity:High FDA (Devices)·Z-2628-2017·Announced 2017-07-05

Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (wrong results) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of its Merge LIS software. The system is used for ordering, managing, and reporting patient laboratory work. The recall affects versions V3.7 through 4.1.4.

The recall is due to potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified. This could lead to incorrect patient laboratory data being reported.

The affected software was distributed nationwide to facilities and distributors, as well as to the Virgin Islands and foreign locations. There was no military or government distribution. A total of 638 sites have the potentially affected versions. Users should contact Merge Healthcare for further instructions on how to address the issue.

The recalled product

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.
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Laboratory Information System
Hazard: incorrect-results
software-defect
Affected units: 638

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Merge Healthcare, Inc.

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