Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD PCR Cartridges used with MAX System. Model Number: 437519

Recall date
December 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1004-2025
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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