FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Recall number
- Z-2115-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Status
- Completed
- Initiated
- 2025-02-27
- Posted
- 2025-07-11
- Terminated
- not on file
- Reason
- 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
- Process control
- Action
- 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.
- Quantity
- 10,000 units
- Distribution
- 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
- Lot, serial or model codes
- UDI-DI: 15099590224301; Lot Number: 439850
- 510(k) numbers
- ["K955436"]
- PMA numbers
- not on file
- Product code
- CDD
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28