Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent

Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

An URGENT MEDICAL DEVICE RECALL notification letter dated 2/19/25 was sent to customers. ACTION: Discontinue using Access Vitamin B12 reagent lot 439850. Discard all remaining reagent packs from this lot following your laboratory procedures. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient results. Contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com You may request replacement product by contacting your local Beckman Coulter Representative for replacement.

• FDA enforcement recordOfficial FDA database entry for Z-2115-2025
• FDA 510(k) clearance · K955436The device's official FDA premarket clearance record
• FDA device classification · CDDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1810The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter, 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.