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 settings.
FDA Recall Z-1662-2013 · Posted 2013-07-03
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeNJR
Date Initiated2013-05-31
Date Terminated2013-08-19
Product Quantity71 instruments
Reason for Recall
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Firm Action
Becton Dickinson (BD) notified their customers in the US by phone on May 31, 2013 and by an Urgent Field Correction Action letter dated May 2013. Customers were advised of the affected product, problem and actions to be taken. The letter informed customers that an onsite visit by a BD Service representative is planned to perform a system check so to determine if the instrument is affected. BD's field service team plans to immediately replace the module on site if the affected part is found. For questions contact BD Technical Services Department at 1-800-638-8663.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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