Sunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination
Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.
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 involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Sunquest Information Systems, Inc. is recalling 9 units of the Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, version 3.0.0_07222004 and later. The recall was initiated because the company confirmed reports that the software interface is combining patient orders inappropriately.
The affected software was distributed nationwide. This recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
- Manufacturer
- Sunquest Information Systems, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 9
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 (1)
- v3.0.0_07222004 and later
Distribution
Distributed nationwide across the United States.
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