Recall Z-0701-2013 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Becton Dickinson & Co.
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
| Date | Jan 22, 2013 (initiated Sep 18, 2012) |
| Status | Terminated |
| Reason | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. |
| Root cause | Device Design |
| Action | Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recal |
| Quantity | 86 Instruments |
| Distribution | USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan. |
| 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 |