BD PCR Cartridges used with MAX System. Model Number: 437519 recallZ-1004-2025 · Becton Dickinson & Co. · initiated Dec 19, 2024

Why it was recalled

Potential for signal drift in specific lots of BD PCR Cartridges.

FDA root cause category: Under Investigation by firm

What the company is doing

BD notified consignees via email and mail on about 12/19/2024 with a letter titled, URGENT: Medical Device Product Correction. Consignees were informed regarding when they can and cannot use the affected BD PCR Cartridges. They were instructed to inspect inventory for affected cartridges, ensure the recall notification is read and understood by all affected personnel, to provide the notification to all affected personnel and customers if further distributed, to complete and return the Customer Response Form, and to report any adverse events associated with the affected units. Distributors were provided the same information and instructions, but were also instructed to provide a copy of the letter to their customers.

Recall details

Recall number

Z-1004-2025

Status

Open, Classified

Initiated by the company

Dec 19, 2024

Posted by the FDA

Jan 21, 2025

Recalling firm

Becton Dickinson & Co.

Quantity

516,435 units

Product code

NJR

FDA submissions

K111860

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.

Product description

BD PCR Cartridges used with MAX System. Model Number: 437519

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BD PCR Cartridge 437519

  Becton, Dickinson And Company · real time Nucleic acid amplification system
  1 recall140 reports

Other devices under the same FDA submission

1 device cleared under K111860 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• BD MAX™ GBS 441772

  Becton, Dickinson And Company · Nucleic acid amplification assay system, group b streptococcus, direct specimen test
  38 reports