100 ml Test Kit - Pearls 100u./Reagent 1x7,5mL / Adjusters mL (lyophilized) 2x4mL (commercially available) Product Name: IGF-I - IMMULITE (Anvisa Record No. 10345161109) /// Affected Model (s) / Solution 1x30mL /// Affected lot: 411 /// Product risk class: II. 의 안전성 경고

Safety alert

1896

2016-05-11

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Siemens healthcare diagnostics has identified that incubation prior to the processing of patient samples takes 24 minutes in the immulite / immulite 1000 system so that the pretreatment solution reaches full equilibrium when using the pre-treatment solution (lgfa) lot 055 , contained in the immulite 2000 igf-i kit, batch 411. if patient samples are processed before full equilibrium is reached, an underestimate recovery of -36% may occur. however, if the sample is incubated for more than 24 minutes before the test, an underestimate will not be observed. there is a potential for a falsely suppressed igf-i value that may delay the diagnosis for acromegaly and / or potential pharmacological treatment to normalize serum igf-i. the impact of clinical potential is mitigated by serum igf-i monitoring as well as by correlation of serum growth hormone dosages and clinical presentation. quality controls will not detect this problem.

Field classification: letter to the client /// Field action code: IMC 16-05 /// Recommendations to users and patients: ensure that the pre-treatment solution is incubated with the patient sample for at least 24 minutes prior to processing in the IMMULITE / IMMULITE 1000 systems.