Recall Z-1004-2025 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Becton Dickinson & Co.
BD PCR Cartridges used with MAX System. Model Number: 437519
| Date | Jan 21, 2025 (initiated Dec 19, 2024) |
| Status | Open, Classified |
| Reason | Potential for signal drift in specific lots of BD PCR Cartridges. |
| Root cause | Under Investigation by firm |
| Action | BD notified consignees via email and mail on about 12/19/2024 with a letter titled, URGENT: Medical Device Product Correction. Consignees were informed regarding when they can and cannot use the affected BD PCR Cartridges. They were instructed to inspect inventory for affected cartridges, ensure the recall notification is read and understood by all affected personnel, to provide the notification to all affected personnel and customers if further distributed, to complete and return the Customer Response Form, and to report any adverse events associated with the affected units. Distributors w |
| Quantity | 516,435 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, T |
| 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 |