Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges

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

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

An URGENT PRODUCT CORRECTION NOTIFICATION was mailed to consignees. The notification to distributors instructs consignees to forward the provided notification and Customer Confirmation Receipt to all customers who were shipped affected lots and to discontinue distributing affected lots. Affected lots in possession of distributors should be discarded. Distributors are asked to return a completed Distributor Confirmation Receipt form. The notification to customers instructs consignees to check their inventory and destroy any identified product subject to this recall. Consignees are instructed to post the provided notification near all VITROS devices and within device User Documentation until the issue has been resolved. A copy of the recall notification should be forwarded if a unit was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form.

• FDA enforcement recordOfficial FDA database entry for Z-1876-2025
• FDA 510(k) clearance · K152433The device's official FDA premarket clearance record
• FDA 510(k) clearance · K953197The device's official FDA premarket clearance record
• FDA device classification · DCKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.5270The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ortho-Clinical Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.