—#214222

Product

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

FDA product code: CDD — Radioassay, Vitamin B12
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K955436
Affected lot / code info: UDI-DI: 15099590224301; Lot Number: 439850

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: International distribution to the country of Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland

Timeline

Recall initiated: 2025-02-27
Posted by FDA: 2025-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.