Home / Recalls / Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. / Z-1741-2022

Z-1741-2022 Class III

Recalled by Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. — Whitestown, IN

Recall Details

Product Type: Devices
Report Date: September 21, 2022
Initiation Date: August 16, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

PTS Panels CHOL+GLU Test Strips (REF 1765)

Reason for Recall

Incorrect instructions for use were packaged into the final product.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.

Code Information

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