Becton Dickinson & Co.: Device Recall
Recall #Z-1004-2025 · 12/19/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1004-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Becton Dickinson & Co.
- Status
- Ongoing
- Date Initiated
- 12/19/2024
- Location
- Sparks, MD, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 516,435 units
Reason for Recall
Potential for signal drift in specific lots of BD PCR Cartridges.
Product Description
BD PCR Cartridges used with MAX System. Model Number: 437519
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.
Other Recalls by Becton Dickinson & Co.
- Class II: Risk 10/23/2025
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.