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Completed

PTS Panels CHOL+GLU Test Strips (REF 1765)

FDA Recall Z-1741-2022 · Posted None

Recalling FirmPolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Recall StatusCompleted
Product CodeCGA
Date Initiated2022-08-16

Reason for Recall

Incorrect instructions for use were packaged into the final product.

Firm Action

PTS Diagnostics notified customers on August 16, 2022, through an Urgent Medical Device Recall letter. Customers were instructed to return product for replacement. Distributors were asked to forward the notice to all customers/users who may have received the product. If you have any questions, please contact PTS Diagnostics' Customer Service directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or 877-570-8610 (U.S. toll-free).

Root Cause

Labeling Change Control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016-12-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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