Device product
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
Z-1629-2015
Product summary
- Event
- Event 71006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 155 kits
- Official record key
device-enforcement:Z-1629-2015
Official wording
Reason: IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values.
Code information: LOT 0257, SMN 10381643
Distribution pattern: Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.
Derived failure modes
-
Unknown
IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values.