Radioimmunoassay, Luteinizing Hormone
Clinical Chemistry · 21 CFR 862.1485
Recent MDR events
74 adverse event reports on file
- WALGREENS OVULATION KITDec 14, 2023InjuryUnkMW5149292
- VIDAS LHJun 5, 2015MalfunctionBiomérieux Sa3002769706-2015-00040
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00673
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00685
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00674
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00675
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00682
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00683
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00684
- ACCESS HLHOct 6, 2014InjuryBeckman Coulter2122870-2014-00686
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- Biomerieux IncOpen, ClassifiedJan 4, 2023
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0865-2023 · View FDA record ↗ - Beckman Coulter Inc.TerminatedDec 20, 2012
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human ser
Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
Z-0572-2013 · View FDA record ↗ - Abbott Laboratories MPGTerminatedJan 11, 2007
ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C
The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.
Z-0488-2007 · View FDA record ↗ - bioMerieux, Inc.Open, ClassifiedUnknown
VIDAS LH, REF 30406-01
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 potential delayed results as the user must run another test.
Z-0433-2022 · View FDA record ↗ - Ortho-Clinical Diagnostics, IncOpen, ClassifiedUnknown
VITROS Immunodiagnostic Products LH Reagent Pack
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.
Z-1113-2022 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK LH II; Part Number: 025296
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2090-2018 · View FDA record ↗
Registered firms
102 firms currently registered for this product code
Eazebio
Livermore, CA, US
Vitrolife Inc.
San Diego, CA, US
Computime Ltd.
LONGGANG REGION, SHENZHAN Guangdong, CN
Diagnostics Biochem Canada, Inc.
London Ontario, CA
Princeton Biomeditech Corp.
Monmouth Jct, NJ, US
Abon Biopharm (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Shenzhen Yhlo Biotech Co., Ltd.
Shenzhen Guangdong, CN
Aceso Laboratories Inc.
Chino, CA, US
Monobind, Inc.
Lake Forest, CA, US
Bioteke Corporation (wuxi) Co., Ltd
Wuxi City Jiangsu, CN
Aid United International Co., Limited
SHANGHAI, CN
Church & Dwight Co., Inc.
PRINCETON, NJ, US
Spd Development Company Limited
Bedford, GB
Naturalcycles Nordic Ab
Stockholm, SE
Diamond Diagnostics Inc.
Budapest, HU
Polygreen (hk) Co., Ltd.
Kowloon Hong Kong, CN
Biomerica
Irvine, CA, US
Ansh Labs, Llc
Webster, TX, US
Immunocentrix Corporation
Canoga Park, CA, US
Diasorin Italia S.p.a.
SALUGGIA Vercelli, IT
Weihai Kangzheng Medical Equipments Technology Co.,ltd
weihai Shandong, CN
Pregmate Llc
Hollywood, FL, US
Abbott Laboratories
Lake Forest, IL, US
Tosoh Corp.
Chuo-ku Tokyo, JP
510(k) clearances
143 clearances for this product code
- Maybe?MomJan 16, 2003
K013582 · MAYBE?MOM MINI OVULATION MICROSCOPE
- Alfa Scientific Designs, Inc.Nov 5, 2002
K022829 · INSTANT-VIEW LH OVULATION PREDICTING TEST
- Phamatech, Inc.May 24, 2002
K021409 · AT HOME OVULATION TEST, MODEL 9032
- Unipath , Ltd.Feb 19, 2002
K013874 · CLEARPLANE EASY OVULATION TEST
- Tci New YorkDec 5, 2001
K013323 · TCI-31 LIFELONG OVULATION TESTER
- ACON Laboratories, Inc.Aug 24, 2001
K012252 · QUIK-CHECK OVULATION PREDICTOR
- Chembio Diagnostic Systems, Inc.May 2, 2001
K010244 · SURE CHECK OVULATION PREDICTOR
- Selfcare, Inc.Oct 12, 2000
K002867 · INVERNESS MEDICAL OVULATION PREDICTOR TEST