Reported Sep 5, 2012 · Terminated

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Sunquest Information Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sunquest Information Systems, Inc. · 250 S Williams Blvd · Tucson, AZ · 85711-4472

Is this the product you have?

  • Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Lot codes and dates
  • Versions 6.4 and later
Amount recalled
127 sites

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 27, 2012 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.