BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results
Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device that may produce 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 198 units of the BD BACTEC FX diagnostic instrument, including Top Unit (catalog number 441385) and Bottom Unit (catalog number 441386) configurations. The instruments are manufactured by BD Diagnostic Systems and are designed for the rapid detection of bacteria and fungi in clinical specimens.
The recall is due to an improperly functioning component that may cause false negative results in clinical specimens. This means the device might fail to detect the presence of bacteria or fungi in patient samples.
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. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 198
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 441385 and 441386
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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