Z-1012-2010

PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by...

Name: Z-1012-2010 PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by...
Creator: Polymer Technology Systems, Inc.
Published: 2009-08-04
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2009-08-04 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN on 2009-08-04. The reason FDA records is "Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1012-2010
Status: Terminated
Initiated: 2009-08-04
Posted: 2010-03-05
Terminated: 2010-10-20
Recalling firm: Polymer Technology Systems
Product: PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
FDA root cause: Other
Action: Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US).
Quantity in commerce: 962
Distribution: Nationwide.
Product codes and lots: Lot I891.

Product code CGA

K071507Class IIPts Panels Chol+hdl+glu Panel Test StripsPolymer Technology Systems, Inc. / cleared 2007-09-10

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)