FX2N-32CCL-NP CC-Link SYSTEM LOCAL BLOCK HARDWARE MANUAL JY992D96001A This manual contains text, diagrams and explanations which will guide the reader in the correct installation. Further information can be found in the FX series PLC hardware manuals. BACTEC™ Fluorescent Series User’s Manual 2. BD BACTEC™ 9000 Systems: A World of Difference in Blood Culture Page 3 07/2014 Figure 2 Fluorescent Technology and Sophisticated Algorithms: a Powerful Combination BMS DIAGNOSTICS (M) SDN BHD (485573-V) 19, Jalan 4/62A, Bandar Menjalara, Kepong, 52200 Kuala Lumpur, Malaysia.
PMID: 7494044
The BD BACTEC FX, latest among the bactec blood culture system, is a fully automated microbiology growth and detection system designed to detect microbial growth from blood specimens. It uses fluorescent technology with an exceptional performance, improving workflow efficiencies from specimen collection to actionable results. The BACTEC 9240 blood culture system (Becton Dickinson Diagnostic Instrument Systems, Sparks, Md.) is one of three automated, continuous-monitoring systems that is widely used in clinical laboratories. The BACTEC 9240 was compared with the BACTEC NR 660 for the detection of organisms and bacteremic. BD Diagnostics: Bactec™ FX and BD MAX12 months. 9240 for the same location 441398 FX Software and CD Users Manual, 441510 CD for Use. Currently, both manual and automated blood culture systems are available, with the market being dominated increasingly by instrument-based automated. BACTEC 9240 system (Becton, Dickinson Co. Mar 25, 2019 BACTEC™ FX40 SYSTEM SERVICE TRAINING MODULE B MODULE B 3 Topic 1: System Overview The FX40 instrument is a BACTEC FX derivative instrument design for price sensitive, low volume emerging market labs. The instrument will leverage the design of BACTEC FX measurement system and FX “Vial Activated Workflow”.
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Abstract
The BACTEC 9240 blood culture system (Becton Dickinson Diagnostic Instrument Systems, Sparks, Md.) is one of three automated, continuous-monitoring systems that is widely used in clinical laboratories. The BACTEC 9240 was compared with the BACTEC NR 660 for the detection of organisms and bacteremic episodes; time to detection of positive cultures; number of false-positive and false-negative cultures; and time needed to load, process, and perform quality control functions by using high-volume aerobic media. Blood specimens (5,282) were inoculated in equal volumes (5 to 10 ml per bottle) into BACTEC Plus Aerobic/F (9240 system) and BACTEC Plus NR26 (660 system) bottles. Clinically significant isolates were detected in 6.6% of cultures, representing 348 microorganisms and 216 bacteremic episodes. Two hundred forty-eight microorganisms were detected by both systems, 48 by the 9240 only and 52 by the 660 only (P = not significant). Of the bacteremic episodes, 158 were detected by both systems, 27 by the 9240 only and 31 by the 660 only (P = not significant). Analysis of data by month revealed equivalent recovery rates for both systems, with the exception of a 30-day period at one study site during which the 660 system detected significantly more microorganisms. Following a proprietary hardware design retrofit of the 9240 instrument, detection rates were again equivalent for the remaining three months at this study site. Positive cultures detected by both systems were detected an average of 4.3 h faster by the 9240 system (21 versus 25.3 h). The numbers of false-positive cultures for the 9240 and 660 systems were 40 (1.0%) and 9 ( < 1.0%), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
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Bactec Fx Procedure Manual
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
Nolte FS, Williams JM, Jerris RC, Morello JA, Leitch CD, Matushek S, Schwabe LD, Dorigan F, Kocka FE. Multicenter clinical evaluation of a continuous monitoring blood culture system using fluorescent-sensor technology (BACTEC 9240). J Clin Microbiol. 1993 Mar;31(3):552–557.[PMC free article] [PubMed] [Google Scholar]
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Articles from Journal of Clinical Microbiology are provided here courtesy of American Society for Microbiology (ASM)
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Class 2 Device Recall BACTEC' FX System Software
Date Initiated by Firm
August 10, 2010
Date Posted
June 23, 2011
Recall Status1
Terminated 3 on July 05, 2011
Z-2626-2011
Recall Event ID
58873
K915796A
System, blood culturing - Product CodeMDB
Product
BACTEC' FX System Software, catalog #441398 and #441750 The BD BACTEC' FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
Becton Dickinson & Co. BD Diagnostic Systems 7 Loveton Circle Sparks MD 21152-0999
For Additional Information Contact
Kimberly Cartier 410-316-4000
In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
Software design
BD Diagnostics Systems sent an 'URGENT PRODUCT RECALL' letter dated August 2010 to all affected customers. The letter describes the product, problem and action to be taken. The letter described the type of error messages the customers may experience. All affected units will be scheduled for on site software update as well as a disk drive replacement. A BD field service engineer will contact the customers to schedule the on site visit. Customers experiencing issues prior to the scheduled visit or have questions should contact the BD Diagnostics Service Department at 800-638-8663.
907 units
Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.