Recall Z-1662-2013 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Becton Dickinson & Co.
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.
| Date | Jul 3, 2013 (initiated May 31, 2013) |
| Status | Terminated |
| Reason | Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. |
| Root cause | Component change control |
| 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. |
| Quantity | 71 instruments |
| Distribution | Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT Becton, Dickinson & CO, Feb 16, 2012 |