BD MAX Clinical Diagnostic Instruments Recalled for Minor Defects
Becton Dickinson is recalling 86 BD MAX clinical diagnostic instruments because minor defects may cause erroneous test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes 'minor defects' leading to erroneous results without reporting specific injuries or hospitalizations, fitting the Moderate severity criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Becton Dickinson & Co. is recalling 86 BD MAX (6 channel) clinical diagnostic instruments, catalog number 441916. The recall is due to minor defects in the instruments that could lead to erroneous test results.
The affected instruments were distributed in the United States, including Connecticut, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, New York, Pennsylvania, Rhode Island, Texas, and Wisconsin. They were also distributed internationally to Canada, Europe, and Japan. The specific serial numbers affected are MX0001 to MX0065 and CM0001 to CM0105, including all sequential numbers in between.
Users of these instruments should contact Becton Dickinson & Co. for further instructions on how to address the defect and ensure accurate diagnostic testing.
The recalled product
- Product
- Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 86
Distribution
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