FDA Enforcement
Class II
Terminated
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Recall: Z-2841-2016
·
Reported September 28, 2016
Enforcement
- Recall Number
- Z-2841-2016
- Event ID
- 73995
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 28, 2016
- Initiation Date
- April 15, 2016
- Classification Date
- September 16, 2016
- Termination Date
- April 20, 2017
- Address
- 511 Benedict Ave, Tarrytown, NY, 10591-5005, United States
Description
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
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 Info
SMN Number:10381403 Lot: 411 Expired: 2016-04
Distribution
Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted
Quantity
525 units