BD MAX Instrument Recall for Non-Compliant Electrical Power Module
Becton Dickinson is recalling 71 BD MAX instruments because the installed electrical power module does not meet industry standards as labeled.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a labeling/standards compliance defect with no reported injuries or illnesses.
Plain-English summary
Becton Dickinson & Co. is recalling 71 units of the BD MAX Instrument, catalog #441916. The recall is due to the electrical power module installed on these in vitro diagnostic instruments not meeting industry standards as labeled.
The affected instruments were distributed worldwide, including in the United States, Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile. The specific serial numbers affected are CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272.
The BD MAX System is used for automated amplification and detection of target nucleic acid sequences in clinical, industrial, and research settings. Users should check their instrument serial numbers against the list provided by the manufacturer to determine if their unit is affected.
The recalled product
- Product
- BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 71
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 (7)
- Serial Numbers: CT0173 to CT0249
- CT0253 to CT0260
- CT0262
- CT0263
- CT0265
- CT0269
- and CT0272
Distribution
Distributed nationwide across the United States.
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