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Recall Observatory FDA recall evidence

Device 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

Z-1403-2013

April 04, 2013

Class II

Product summary

Firm
Polymer Technology Systems, Inc.
Event
Event 65067
Status
Terminated
Classification
Class II
Quantity
7048 total, 3499 in USA
Official record key
device-enforcement:Z-1403-2013

Official wording

Reason: Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.