Device product
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Z-2841-2016
Product summary
- Event
- Event 73995
- Status
- Terminated
- Classification
- Class II
- Quantity
- 525 units
- Official record key
device-enforcement:Z-2841-2016
Official wording
Reason: 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.
Code information: SMN Number:10381403 Lot: 411 Expired: 2016-04
Distribution pattern: Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted
Derived failure modes
-
Unknown
24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.