Z-1132-2010

PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by...

Name: Z-1132-2010 PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by...
Creator: Polymer Technology Systems, Inc.
Published: 2008-05-29
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2008-05-29 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis... on 2008-05-29. The reason FDA records is "The expiration date was extended by 20 weeks without justification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1132-2010
Status: Terminated
Initiated: 2008-05-29
Posted: 2010-03-15
Terminated: 2010-10-20
Recalling firm: Polymer Technology Systems
Product: PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.
Product code: MRR System, Test, Low Density, Lipoprotein
Reason for recall: The expiration date was extended by 20 weeks without justification.
FDA root cause: Process change control
Action: An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.
Quantity in commerce: not available.
Distribution: Worldwide distribution
Product codes and lots: Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.

Product code MRR

K040693Class IPts Panels Ldl Cholesterol Test StripsPolymer Technology Systems, Inc. / cleared 2004-07-06

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)