Lower riskMedical device recall · FDA · Published December 19, 2024
BD PCR Cartridges: Signal Drift Risk in Specific Lots
Becton Dickinson recalls BD PCR Cartridges (model 437519) with potential signal drift in specific lots. Affected units have unique UDI numbers listed in the recall notice.
“BD PCR Cartridges: Signal Drift Risk in Specific Lots.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53223-bd-pcr-cartridges-signal-drift-risk-in-specific-lots. Based on FDA recall #Z-1004-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2025%22&limit=1).
Becton Dickinson & Co. recalled BD PCR Cartridges used with MAX System due to potential signal drift, the FDA said on Dec. 19, 2024. Owners should contact the company for a remedy.
How to tell if you have it
BD PCR Cartridges used with MAX System, Model Number: 437519
UPC 30382904375196
The hazard
The recall addresses potential signal drift in specific lots of BD PCR Cartridges, according to the FDA.
Context
GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Other recent recalls include BD GasP: CO2 Pouch System Recall (2026-04-07), BD Kiestra Isolate Suspension Cuvette Array Recall (2025-10-23), and BD BACTEC 9120 Blood Culture System Recall (2025-09-23). Similar product recalls include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07), BD 60-In Extension Sets recall (2026-06-16), and HardyDisk AST Cefiderocol 30μg FDC30 recall (2026-06-08).
How to tell if you have this one
Check if your BD PCR Cartridges have model number 437519 and the specific UDI numbers listed in the recall notice. The UDI numbers follow the format (01)30382904375196(17)XXXXXX(10)XXXXXX.
Brand
Becton Dickinson
Product
BD PCR Cartridges used with MAX System. Model Number: 437519
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Model
Verify your BD PCR Cartridge model number is 437519.
Review UDI Numbers
Check if your cartridge has one of the specific UDI numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 46 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1004-2025 (December 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1004-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.