Reported Sep 21, 2022 · Completed

PTS Panels CHOL+GLU Test Strips (REF 1765)

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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. dba PTS Diagnostics, Inc. · 4600 Anson Blvd · Whitestown, IN · 46075-4489

Is this the product you have?

  • PTS Panels CHOL+GLU Test Strips (REF 1765)
Lot codes and dates
  • Complete UDI(01)00381931765016(17)230627(10)A202
  • UPC Code381931765016 lot A202

Where it was sold

  • Nationwide
  • VA

Why it was recalled

Incorrect instructions for use were packaged into the final product.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 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.