BACTEC" FX Instrument-Top, catalog #441385. 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.
FDA Recall Z-2627-2011 · Posted 2011-06-23
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeMDB
Date Initiated2010-08-10
Date Terminated2011-07-05
Product Quantity907units
Reason for Recall
In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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