Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1876-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 14, 2025

Date Posted: June 4, 2025

Recall Number: Z-1876-2025

Event ID: 96784

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3,587 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated