Polymer Technology Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1403-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 4, 2013

Date Posted: June 5, 2013

Recall Number: Z-1403-2013

Event ID: 65067

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.

Status: Terminated

Product Quantity: 7048 total, 3499 in USA

Code Information:

U1117

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated