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.
This recall has been terminated (originally issued June 23, 2011).
- Recall Initiated
- August 10, 2010
- Posted
- June 23, 2011
- Terminated
- July 5, 2011
- Recall Number
- Z-2627-2011
- Quantity
- 907units
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
Distribution
Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
Lot / Code Info
Catalog # 441385-Serial numbers: FT-0001 to FT-0906 and FT-0922
Root Cause
Software design
Action Taken
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.