Z-1136-2010

PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers...

Name: Z-1136-2010 PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers...
Creator: Polymer Technology Systems, Inc.
Published: 2009-06-05
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2009-06-05 / Terminated / root cause: manufacturing process

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc... on 2009-06-05. The reason FDA records is "Exhibits under-recovery of all analytes". 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-1136-2010
Status: Terminated
Initiated: 2009-06-05
Posted: 2010-03-15
Terminated: 2010-10-20
Recalling firm: Polymer Technology Systems
Product: PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: Exhibits under-recovery of all analytes.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.
Quantity in commerce: Not available.
Distribution: Nationwide and international.
Product codes and lots: Lot P814; exp. 9/2/09.

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)