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