Recall Z-2115-2025 ยท CDD Radioassay, Vitamin B12
Beckman Coulter, Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
| Date | Jul 11, 2025 (initiated Feb 27, 2025) |
| Status | Completed |
| 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 laborato |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955436 | ACCESS VITAMIN B12 ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc., Jan 24, 1996 |