FDA recall Z-1876-2025

Ortho-Clinical Diagnostics, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-04-14
Report date
2025-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1876-2025