Radioimmunoassay, Human Growth Hormone

IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

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.

IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830

The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).

IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part

The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGF

Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)

Under recovery of diluted samples by as much as 20%.

ST-AIA PACK HGH; Part Number: 025266

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.