FDAFDA · Food and drugs·Recall number Z-1403-2013
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
Published June 5, 2013 · Recall initiated: April 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Polymer Technology Systems, Inc.
- Distributor
- 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.
- Lot
- U1117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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