Z-1741-2022Class III

PTS Panels CHOL+GLU Test Strips (REF 1765)

Name: Z-1741-2022 PTS Panels CHOL+GLU Test Strips (REF 1765)
Creator: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Published: 2022-08-16
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2022-08-16 / Completed / root cause: labeling and UDI

FDA source

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. began a recall of PTS Panels CHOL+GLU Test Strips (REF 1765) on 2022-08-16. FDA classified it as Class III and gives the reason as "Incorrect instructions for use were packaged into the final product". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1741-2022
Classification: Class III
Status: Completed
Initiated: 2022-08-16
Posted: 2022-09-14
Recalling firm: Polymer Technology Systems
Product: PTS Panels CHOL+GLU Test Strips (REF 1765)
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Incorrect instructions for use were packaged into the final product.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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).
Distribution: Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Product codes and lots: Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1741-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1741-2022	Class III	Completed	Voluntary: Firm initiated	2022-09-21	2022-09-14

Product code CGA

K162282Class IICardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics / cleared 2016-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)