FDA Device recall Z-2841-2016
IG1, IGF-I reagent, Catalog # LKGF1
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of IG1, IGF-I reagent, Catalog # LKGF1 by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2841-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | FL, IL, LA, MA, MO, NY, OH |
Product
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.
Identifiers
| code_info | SMN Number:10381403 Lot: 411 Expired: 2016-04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2841-2016%22
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