FDA Medical devices recall ·
VITROS Chemistry Products CRP Slides recall
- Recall number
- Z-1876-2025
- Date
- (initiated April 14, 2025)
- Company / brand
- Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr, Rochester, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,587 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Why was it recalled?
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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: Arkansas Arizona Colorado Florida Georgia Idaho Illinois Indiana Kansas Michigan Minnesota Missouri Mississippi Montana North Dakota Nebraska New Hampshire New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Tennessee Texas Virginia Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1876-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.