Home › Device types › JLS
Radioimmunoassay, Progesterone
FDA product code JLS · Class 1 · Clinical Chemistry
79
Registered devices
152
Adverse events
21
Recalls
57
510(k) clearances
Devices with this code
Salimetrics — SALIMETRICS, LLCDimension Vista® Flex® reagent cartridge PROG — Siemens Healthcare Diagnostics Inc.Progesterone — DRG International IncProgesterone — DRG Instruments Gesellschaft mit beschränkter HaftungAccess Progesterone — Beckman Coulter, Inc.ACCESS PROGESTERONE CALIBRATOR S0 — Beckman Coulter, Inc.Progesterone AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.AccuDiag™ Progesterone ELISA — Diagnostic Automation, Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSMP Biomedicals LLC — Mp Biomedicals, LLCPantex — PantexADVIA Centaur® Progesterone (PRGE) — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAlinity — ABBOTT IRELANDSalimetrics — SALIMETRICS, LLCADVIA Centaur® Immunoassay Systems PRGE MCM — Siemens Healthcare Diagnostics Inc.DBC Progesterone ELISA — Diagnostics Biochem Canada IncVIDAS® Progesterone — BIOMERIEUX SAProgesterone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAtellica IM PRGE — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT IRELANDElecsys Progesterone III — Roche Diagnostics GmbHDeltec — ICU MEDICAL, INC.Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2019-07-10 | Siemens Healthcare Diagnostics, Inc. | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration fo |
| 2019-07-10 | Siemens Healthcare Diagnostics, Inc. | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration fo |
| 2019-06-06 | DRG Instruments GmbH | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were |
| 2018-11-21 | Abbott Ireland Diagnostics Division | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Append |
| 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 |
| 2018-02-13 | Tosoh Bioscience Inc | Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the |
| 2018-02-13 | Tosoh Bioscience Inc | Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the |
| 2017-12-22 | Arrow International Inc | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
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