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Recall Observatory FDA recall evidence

Device product

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

Z-1876-2025

April 14, 2025

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 96784
Status
Ongoing
Classification
Class II
Quantity
3,587 units
Official record key
device-enforcement:Z-1876-2025

Official wording

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

Code information: Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, 3788-1291-9975.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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