Device product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Z-1946-2015
Product summary
- Event
- Event 70992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52 kits + 75 kits Beckman Coulter Brand OUS
- Official record key
device-enforcement:Z-1946-2015
Official wording
Reason: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Code information: Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104
Distribution pattern: Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
Derived failure modes
-
Unknown
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.