Z-2641-2010

PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip...

Name: Z-2641-2010 PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip...
Creator: Polymer Technology Systems, Inc.
Published: 2010-07-06
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2010-07-06 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736... on 2010-07-06. The reason FDA records is "The test strips appear to under-recover Cholesterol, HDL and glucose". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2641-2010
Status: Terminated
Initiated: 2010-07-06
Posted: 2010-09-30
Terminated: 2011-05-11
Recalling firm: Polymer Technology Systems
Product: PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: The test strips appear to under-recover Cholesterol, HDL and glucose.
FDA root cause: Other
Action: Distributors and direct customers were notified by letter on July 2, 2010. They were told to discontinue use and dispose of the affected lot of test strips. The firm also asked customers to complete an acknowledgement and confirmation document .
Quantity in commerce: 5805
Distribution: US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
Product codes and lots: Lot number I904

Product code NBW

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)