IG1 — Class II medical device recall Z-2841-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-09-28, distributed in FL, IL, LA, MA, MO, NY, OH. 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to
| Recall number | Z-2841-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2016-04-15 |
| Classified | 2016-09-16 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-04-20 |
| Distributed | FL, IL, LA, MA, MO, NY, OH |
| Countries outside the US | CA |
| Quantity | 525 units |
| Lot numbers | 411 |
| Model numbers | LKGF1 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2841-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.