FDAClass IIISeptember 21, 2022

PTS Panels CHOL+GLU Test Strips recall

PTS Panels CHOL+GLU Test Strips (REF 1765)

Why was PTS Panels CHOL+GLU Test Strips recalled?

Incorrect instructions for use were packaged into the final product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202

Product
PTS Panels CHOL+GLU Test Strips (REF 1765)
Recalling firm
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Distribution
Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Recall date
September 21, 2022
Classification
Class III
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls