--- title: "BD PCR Cartridges used with MAX System. Model Number: 437519 — FDA record Z-1004-2025 | Is It on Recall" description: "Potential for signal drift in specific lots of BD PCR Cartridges." url: https://isitonrecall.com/recall/fda-device-z-1004-2025-bd-pcr-cartridges-used-with-max-system-model-number-437519/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # BD PCR Cartridges used with MAX System. Model Number: 437519 — FDA record Z-1004-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: BD PCR Cartridges used with MAX System. Model Number: 437519 - **Reason**: Potential for signal drift in specific lots of BD PCR Cartridges. - **Classification**: Class II - **Recalling firm**: Becton Dickinson & Co. - **Quantity**: 516,435 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1004-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1004-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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. | Match all identifying details in the current notice. A brand name alone is not enough. ## 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, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jan 29, 2025 - **Recall initiation date**: Dec 19, 2024 - **Center classification date**: Jan 21, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1004-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Becton Dickinson & Co. records](https://isitonrecall.com/brand/becton-dickinson-co/)