Recall Z-1876-2025— Ortho-Clinical Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2025-04-14. It names 2 FDA 510(k) clearances: K152433, K953197. Product: VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.. Reason: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-14
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
- K953197 — EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.