Reported Jan 29, 2020 · Terminated

Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS,…

Polymer Technology 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: Polymer Technology Systems, Inc. · 7736 Zionsville Rd · Indianapolis, IN · 46268-2175

Is this the product you have?

  • Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Lot codes and dates
  • All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe
  • UDI00304040037713
Amount recalled
44,448 total

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

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 Jul 6, 2020 · Data as of Sep 19, 6:14 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.