Radioimmunoassay, Prolactin (Lactogen)

Reports per year

Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2017-05-05TerminatedUnder Investigation by firm

  Dimension Vista Prolactin (PRL) Flex reagent cartridge

  The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

• 2012-09-19TerminatedNonconforming Material/Component

  ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH

  ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

• 2011-04-20TerminatedEquipment maintenance

  Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

  The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio

• Open, ClassifiedDevice Design

  VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

  The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

• Open, ClassifiedDevice Design

  VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

  Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

• TerminatedDevice Design

  ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone

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