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Radioimmunoassay, Prolactin (Lactogen)
FDA product code CFT · Class 1 · Clinical Chemistry
53
Registered devices
248
Adverse events
6
Recalls
80
510(k) clearances
Devices with this code
Alinity — ABBOTT IRELANDIMMULITE® 2000 Systems PRL Prolactin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCL AIA-PACK Prolactin II TEST CUP — TOSOH CORPORATIONAccuDiag™ Prolactin (PRL) ELISA — Diagnostic Automation, Inc.DBC Prolactin ELISA — Diagnostics Biochem Canada IncPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDACCESS PROLACTIN — Beckman Coulter, Inc.IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDProlactin — DRG Instruments Gesellschaft mit beschränkter HaftungAtellica IM PRL — Siemens Healthcare Diagnostics Inc.PAPP-A AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Prolactin ELISA — DRG International IncADVIA Centaur® Prolactin (PRL) — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSAIA-PACK PRL SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONPRL AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.ARCHITECT — ABBOTT IRELANDiFlash-Prolactin — Shenzhen YHLO Biotech Co., Ltd.AIA-PACK PRL CALIBRATOR SET — TOSOH CORPORATIONElecsys Prolactin II — Roche Diagnostics GmbHProlactin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungADVIA Centaur® PRL — Siemens Healthcare Diagnostics Inc.PRLs AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Prolactin ELISA — IBL America
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-25 | Ortho-Clinical Diagnostics, Inc | 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 Imprecis |
| 2018-07-12 | Ortho Clinical Diagnostics Inc | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2017-03-21 | Siemens Healthcare Diagnostics, Inc. | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dime |
| 2012-08-07 | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 |
| 2009-08-03 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values f |
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