Reported Aug 13, 2014 · Terminated

PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate…

PerkinElmer Health Sciences, 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: PerkinElmer Health Sciences, Inc. · 940 Winter St · Waltham, MA · 02451-1457

Is this the product you have?

  • PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6
  • Product Code5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data
Lot codes and dates
  • Product Code
    • 5002-0500
    • Software Versions
    • 1.4 and 1.6
Amount recalled
13 devices

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

Why it was recalled

Potential for demographic information and test result to be mismatch.

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 Apr 6, 2015 · Data as of Sep 19, 5:29 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.