Remel, Inc recalls 1. CAMHB W/LHB

Products may contain contamination, which may result in a darker or brown media color.

On November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters. Customers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.

• FDA enforcement recordOfficial FDA database entry for Z-0585-2026
• FDA 510(k) clearance · K790687The device's official FDA premarket clearance record
• FDA 510(k) clearance · K802957The device's official FDA premarket clearance record
• FDA device classification · JTZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Remel, IncSearch 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.