Z-1004-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 516,435 units
Product Description
BD PCR Cartridges used with MAX System. Model Number: 437519
Reason for Recall
Potential for signal drift in specific lots of BD PCR Cartridges.
Distribution Pattern
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, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao.
Code Information
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, (01)30382904375196(17)260605(10)4142324, (01)30382904375196(17)260604(10)4136790, (01)30382904375196(17)260528(10)4130663,(01)30382904375196(17)260527(10)4130589, (01)30382904375196(17)260520(10)4121669, (01)30382904375196(17)260517(10)4117376, (01)30382904375196(17)260513(10)4114952, (01)30382904375196(17)260506(10)4107497, (01)30382904375196(17)260429(10)4100041, (01)30382904375196(17)260422(10)4093507.