Bd Bactec Fx 40 User Manual

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Bd Bactec Fx40 Manual

Manual

User’s Manual). The sensor inside the bottle will not appear visibly different in positive and negative vials, however the BD BACTEC fluorescent series instrument can determine a difference in fluorescence. Blood will lyse immediately upon addition to the BD BACTEC Lytic/10 Anaerobic/F Medium. BACTEC™ 9240/9120/9050 (BACTEC Fluorescent Series) Microorganisms, if present in the blood samples, metabolize nutrients in the. PP-088E BD Biosciences. Document Number MA - 0074. BD Biosciences. BACTEC 9050 System User’s Manual. Document Number MA-0103. BD Biosciences. BACTEC Blood Culture Procedural Trays. Jun 14, 2014  BD BACTEC FX40 Blood Culture Instrument Now Communicates with the BD EpiCenter Data Management System. Product News Jun 14, 2014. The BACTEC FX and the BD BACTEC 9000 families of continuous monitoring blood culturing instruments offer performance, safety, reliability, ease of use, media quality and service to meet the needs of today's top. Bd Bactec Fx 40 User Manual Bactec Fx 40 User Manual Vtech Cs6719 Dect 6.0 Expandable Cordless Phone System Users Manual Jive Phone System Users Manual Kia Niro Car Multimedia System Users Manual Hologic Affirm Prone Biopsy System Users Manual Guava Pca-96 System Users Manual Page 2.

Bactec Fx Specifications

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Bd Bactec Fx40 User Manual

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Class 2 Device Recall BD BACTEC FX 40 instrument
Date Initiated by FirmDecember 09, 2013
Date PostedJanuary 30, 2014
Recall Status1Terminated 3 on August 20, 2014
Z-0870-2014
Recall Event ID67245
K915796
System, blood culturing - Product CodeMDB
ProductBD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152.
The 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.
Code InformationCatalog number 442296
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information ContactMs. Gail Claiborne
410-316-4054
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Nonconforming Material/Component
BD Diagnostics initiated a field correction by phone on December 9, 2013, to affected customers and followed the calls with letters, e-mails, or fax. BD Diagnostics sent a secondary Urgent Field Corrective Action letter dated November 2013 to all affected customers. The recalling firm Secondary notifications were serial number specific and explained that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights which should appear yellow may instead appear more green in color. BD noted that affected instruments continue to function properly and will not report an incorrect result. The issue is limited to the yellow indicator lights only. Red and green indicator lights appear as intended. BD is developing software to correct this issue and anticipates that the new software will be available to begin instrument updates by February, 2014. The new software will not affect instrument if the indicator lights are functioning as intended. Until the software can be updated on your instrument, BD provided workflow instructions to ensure that the indicator light issue does not occur. For questions regarding this recall call 410-316-4054.
2 units
Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
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.
510(K) Database510(K)s with Product Code = MDB and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC