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U.S. Department of Health and Human Services

Class 2 Device Recall BACTEC" FX System Software

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  Class 2 Device Recall BACTEC" FX System Software see related information
Date Initiated by Firm August 10, 2010
Date Posted June 23, 2011
Recall Status1 Terminated 3 on July 05, 2011
Recall Number Z-2626-2011
Recall Event ID 58873
510(K)Number K915796A  
Product Classification System, blood culturing - Product Code MDB
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.
Code Information Catalog # 441398-Serial numbers:V100E, V101F, V200B, V210A, V220B, V221A, and V230B  Catalog # 441750-Serial number: V100A  
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kimberly Cartier
410-316-4000
Manufacturer Reason
for Recall		 In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 907 units
Distribution Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
Total Product Life Cycle 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.
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