FDA Device

Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

Hazard

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.

What You Should Do

Remedy

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.

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Products

Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Brand
Sunquest Information Systems, Inc.
UPC
Versions 6.4.0 and later

Units Affected

127 sites

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