Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

BD PCR Cartridges Recalled Due to Potential for Signal Drift

Agency Publication Date: January 21, 2025
Share:
Sign in to monitor this recall

Summary

Becton Dickinson & Co. (BD) is recalling 516,435 units of BD PCR Cartridges used with the MAX System due to the potential for signal drift in specific lots. This technical defect can lead to inaccurate test results, which may affect clinical diagnoses. No injuries or incidents have been reported in connection with this issue.

Risk

The cartridges may experience signal drift, which can cause the diagnostic system to provide incorrect results. This poses a risk of false positive or false negative findings, potentially leading to incorrect medical treatments or delayed care for patients.

What You Should Do

  1. This recall affects BD PCR Cartridges used with the MAX System, identified by Model Number 437519.
  2. Check the product label or packaging for specific Unique Device Identifier (UDI) numbers to confirm if your cartridges are from an affected lot. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Becton Dickinson & Co. or your authorized medical distributor to arrange for the return, replacement, or correction of the affected cartridges.
  5. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD PCR Cartridges used with MAX System
Model / REF:
437519
Serial 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
UDI:
(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

Recalled units are used with the MAX System.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95963
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 516,435 units
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.