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Terminated

Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

FDA Recall Z-0251-2013 · Posted 2012-11-06

Recalling FirmSunquest Information Systems, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2009-11-19
Date Terminated2012-11-06
Product Quantity9 units

Reason for Recall

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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