BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction
FDA device recall Z-1662-2013 · posted 2013-07-03 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
- Action taken
- 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
- Status
- Terminated
- Product code
- NJR
- Quantity affected
- 71 instruments
- Distribution
- Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
- Date initiated
- 2013-05-31
- Date posted
- 2013-07-03
- Date terminated
- 2013-08-19
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD MAX GBS ASSAY, BD MAX INSTRUMENT (K111860) | Becton, Dickinson & CO | 2012-02-16 |