BD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results
Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic medical device where a defect may cause false negative results, posing a risk of harm to patients through missed diagnoses, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling two units of the BD BACTEC FX 40 instrument, catalog number 442296. 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.
The recall is due to an improperly functioning component that may cause false negative results in clinical specimens. The affected units were distributed nationwide in the United States and internationally to India, Australia, China, Argentina, Belgium, Peru, South Korea, Brazil, Colombia, Singapore, Thailand, Brunei, Hong Kong, Japan, and Canada.
Healthcare facilities and consumers who have this product should stop using it and contact Becton Dickinson & Co. for further instructions.
The recalled product
- Product
- BD 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 i
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number 442296
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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