MAUDE Adverse Event Report | 合法醫療器材資訊網
Thecustomerhasobtainedoutofrangevaluesforqualitycontrol(qc)samplesonthedehydroepiandrosteronesulfate(dhea-so4)assayonanimmulite2000 ...
References
Search Alerts/Recalls
(www.fda.gov)
Model Number IMMULITE 2000
Device Problem Low Test Results
(2458)
Patient Problem No Known Impact Or
Consequence To Patient (2692)
Event Date 10/13/2014
Event Type malfunction
Event Description
The customer has obtained out of range values for quality control (qc) samples on the dehydroepiandrosterone sulfate (dhea-so4) assay on an immulite 2000 instrument.Patient sample values were reported to physician(s) despite qc levels 1 and 2 being out of range high, and qc level 3 being out of range low.Discordant (dhea-so4) results were obtained for four patient ...
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IMMULITE 2000 DHEA | 合法醫療器材資訊網
IMMULITE 2000 DHEA-S: Dehydroepiandrosterone Sulfate Reagent 200 Count Contains (1) Bead Pack/ (1) 11.5mL Reagent Wedge Each. Read More
immulite® 2000 dhea | 合法醫療器材資訊網
IMMULITE 2000 DHEA-SO4 (PIL2KDS-21, 2015-06-17). English. Intended Use: For in vitro diagnostic use with the IMMULITE® 2000 Systems. Analyzers — for ... Read More
DHEA | 合法醫療器材資訊網
IMMULITE/IMMULITE 1000 DHEA-SO4 (PILKDS-19, 2015-07-10). English ... Testosterone. 2000. 0.83. 0.042%. ND: not detectable.5. Method Comparison. Read More
SECTION 5 | 合法醫療器材資訊網
2015年6月9日 — Trade/Device Name: IMMULITE® 2000 CEA Calibration Verification Material ... IMMULITE® 2000 DHEA-SO4 Calibration Verification Material. Read More
Establishment Registration & Device Listing | 合法醫療器材資訊網
Proprietary Name: IMMULITE 2000 DHEA-SO4; IMMULITE 2000 Multi-Diluent 1; IMMULITE DHEA-SO4 Sample Diluent; IMMULITE/IMMULITE 1000 DHEA-SO4. Read More
MAUDE Adverse Event Report | 合法醫療器材資訊網
The customer has obtained out of range values for quality control (qc) samples on the dehydroepiandrosterone sulfate (dhea-so4) assay on an immulite 2000 ... Read More
immulite® 2000 dhea | 合法醫療器材資訊網
2018年6月27日 — IMMULITE 2000 DHEA-SO4 (PIL2KDS-26, 2018-06-27). English. Intended Use: For in vitro diagnostic use with the IMMULITE® 2000 Systems. Read More
Reference Ranges for Serum Dehydroepiandrosterone ... | 合法醫療器材資訊網
由 N Friedrich 著作 · 2008 · 被引用 62 次 — 2000; Harman et al, 2001; Liu et al, 2007) and has been implicated in a wide ... (Siemens IMMULITE 2500 DHEA-SO4, ref L5KDS, lot 106,. Read More
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