FDA Medical Device Recalls (openFDA)
Sunquest Information Systems, Inc.: Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
- Recall number
- Z-0251-2013
- Recalling firm
- Sunquest Information Systems, Inc.
- Product
- Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
- Status
- Terminated
- Initiated
- 2009-11-19
- Posted
- 2012-11-06
- Terminated
- 2012-11-06
- Reason
- The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
- Root cause
- Nonconforming Material/Component
- Action
- Sunquest sent an "URGENT-PRODUCT SAFETY NOTICE: PSN-09-06" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.
- Quantity
- 9 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- v3.0.0_07222004 and later
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000306472
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28