Class II

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

Ortho-Clinical Diagnostics, Inc. · April 14, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

3,587 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1876-2025

Status: ongoing

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