FDA Medical Device Recalls (openFDA)
Sunquest Information Systems, Inc.: Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
- Recall number
- Z-0073-2013
- Recalling firm
- Sunquest Information Systems, Inc.
- Product
- Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
- Status
- Terminated
- Initiated
- 2011-11-15
- Posted
- 2012-10-17
- Terminated
- 2012-10-19
- Reason
- Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
- Root cause
- Software design
- Action
- Urgent - Product Safety Notice: PSN-11-06,dated, 15 November 2011, was sent to customers. Costumers should follow instructions in the notification letter. To request the software correction, create a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Return receipt acknowledging PSN-11-06 is required . Client Support can be reached at 1-877-239-6337 for U.S. and Canadian sites and at +44 (0) 161 335 0562 for International sites.
- Quantity
- 127 sites
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Versions 6.4.0 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