Z-0871-2010

PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers...

Name: Z-0871-2010 PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers...
Creator: Polymer Technology Systems, Inc.
Published: 2009-04-02
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2009-04-02 / Terminated / root cause: manufacturing process

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc... on 2009-04-02. The reason FDA records is "The memory chip was coded with incorrect product information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0871-2010
Status: Terminated
Initiated: 2009-04-02
Posted: 2010-03-01
Terminated: 2010-10-20
Recalling firm: Polymer Technology Systems
Product: PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: The memory chip was coded with incorrect product information.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Polymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.
Quantity in commerce: 486 vials
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: C908.

Product code CHH

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)