Z-1403-2013Class II

PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers

Name: Z-1403-2013 PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers
Creator: Polymer Technology Systems, Inc.
Published: 2013-04-04
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2013-04-04 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to... on 2013-04-04. FDA classified it as Class II and gives the reason as "Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1403-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-05-25
Terminated: 2014-04-16
Recalling firm: Polymer Technology Systems
Product: PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
FDA root cause: Under Investigation by firm
Action: Polymer Technology Systems sent a Field Correction Action letters dated April 4, 2013 to distributors and customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use and dispose of remaining inventory of recalled product. Customers were asked to acknowledge and confirm recall directions were follwed by fax to 1-317-870-5608.
Quantity in commerce: 7048 total, 3499 in USA
Distribution: Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
Product codes and lots: U1117

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1403-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1403-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code NBW

K013068Class IIBioscanner 2000Polymer Technology Systems, Inc. / cleared 2001-11-20

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)