MAUDE Adverse Event Report | 合法醫療器材資訊網
...depressedsirolimus(siro)patientresultobtainedonthedimensionexlwithlminstrument....TypeofDevice,SIROLIMUSFLEX®REAGENTCARTRIDGE.
References Search Alerts/Recalls (www.fda.gov) Catalog Number DF306 SMN 10464331 Device Problem Low Test Results (2458) Patient Problem No Consequences Or Impact To Patient (2199) Event Date 03/15/2019 Event Type malfunction Manufacturer NarrativeMdr 2517506-2019-00181 was filed for the same event.The customer contacted the siemens customer care center (ccc) and reported a discordant depressed sirolimus (siro) patient result obtained on the dimension exl with lm instrument.Siemens is investigating the event.
Event Description ...
"Dimension" SIRO Sirolimus Flex reagent cartridge "Dimension" SIRO Sirolimus Flex reagent cartridge 春杏醫療儀器有限公司 “況特”眼科雷射光凝儀 血氧手錶 台灣製血氧機 血氧偵測用途 淨頌 灌腸袋 (未滅菌) 氣管內管 中美生醫 仙同假牙黏著劑 (未滅菌)
510(k) Premarket Notification | 合法醫療器材資訊網
2008年10月30日 — Device Name, DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306. Read More
Class 2 Device Recall Dimension Sirolimus (SIRO) Flex | 合法醫療器材資訊網
2018年5月4日 — Product, Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge. Code Information, SIRO, sirolimus test system, DF306, SMN# 10464331 Lot ... Read More
Class 2 Device Recall Dimension Sirolimus (SIRO) Flex ... | 合法醫療器材資訊網
2016年5月10日 — Product, Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well ... Read More
Dimension Siro Flex Reagent Cartridge And Dimension Sirolimus ... | 合法醫療器材資訊網
FDA premarket device registration for Dimension Siro Flex Reagent Cartridge And Dimension Sirolimus Calbirator, Models Dr 306, Dc 306 distributed by ... Read More
Dimension SIRO Reagent Cartridge | 合法醫療器材資訊網
Recall began: February 9, 2016. Device(s):Dimension Sirolimus (SIRO) Flex Reagent Cartridge (DF306 SMN 10464331), lot EB6064 (Recall # Z-1633-2016). Read More
International Medical Devices Database | 合法醫療器材資訊網
Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability || The SIRO method is ... Read More
MAUDE Adverse Event Report | 合法醫療器材資訊網
Investigation determined that dimension siro lot eb6064 does not meet the open ... Brand Name, DIMENSION® SIROLIMUS FLEX® REAGENT CARTRIDGE. Read More
MAUDE Adverse Event Report | 合法醫療器材資訊網
... depressed sirolimus (siro) patient result obtained on the dimension exl with lm instrument. ... Type of Device, SIROLIMUS FLEX® REAGENT CARTRIDGE. Read More
相關資訊整理
【"德曼遜" 西羅莫司 弗列克斯 試劑組】許可證字號:衛署醫器輸字第020826號
器材品名:"德曼遜"西羅莫司弗列克斯試劑組許可證字號:衛署醫器輸字第020826號註銷狀態:註銷日期:註銷理由:有效日期:2025/02/...