Recall Z-1004-2025
Becton Dickinson & Co. · initiated December 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD PCR Cartridges used with MAX System. Model Number: 437519
Codes / lots: Model Number: 437519. UDI Numbers: (01)30382904375196(17)261205(10)4323345, (01)30382904375196(17)261129(10)4317725, (01)30382904375196(17)261122(10)4309022, (01)30382904375196(17)261115(10)4302135, (01)30382904375196(17)261111(10)4296086, (01)30382904375196(17)261104(10)4289593, (01)30382904375196(17)261029(10)4281532, (01)30382904375196(17)261021(10)4275828, (01)30382904375196(17)261014(10)4268747, (01)30382904375196(17)261007(10)4254714, (01)30382904375196(17)260930(10)4254710, (01)30382904375196(17)260923(10)4247089, (01)30382904375196(17)260913(10)4239079, (01)30382904375196(17)260909(10)4233297, (01)30382904375196(17)260902(10)4225364, (01)30382904375196(17)260826(10)4204545, (01)30382904375196(17)260805(10)4198065, (01)30382904375196(17)260729(10)4191581, (01)30382904375196(17)260722(10)4185634, (01)30382904375196(17)260716(10)4178328, (01)30382904375196(17)260704(10)4164798, (01)30382904375196(17)260701(10)4164796, (01)30382904375196(17)260701(10)4164792, (01)30382904375196(17)260701(10)4164794, (01)30382904375196(17)260701(10)4164789, (01)30382904375196(17)260624(10)4149773, (01)30382904375196(17)260617(10)4149768, (01)30382904375196(17)260610(10)4143963…
Reason for recall
Potential for signal drift in specific lots of BD PCR Cartridges.
FDA-determined cause: Under Investigation by firm
Action taken
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 were provided the same information and instructions, but were also instructed to provide a copy of the letter to their customers.
Details
- Recall number
- Z-1004-2025
- Initiated
- December 19, 2024
- Posted by FDA
- January 21, 2025
- Product code
- NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- 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, Taiwan, Australia, Singapore, Mexico, Hong Kong, India, Japan, Columbia, Brazil, Philippines…
- Recalling firm
- Becton Dickinson & Co., Sparks, MD