Medical device recalls Moderate risk

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of…

Recall date
April 14, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1876-2025
FDA classification
Class II
Brand / firm
Ortho-Clinical Diagnostics, Inc.
Sold / distributed
Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy, Mexico & Singapore.

Why it was recalled

Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

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

What was recalled

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.

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