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Recall Observatory FDA recall evidence

Device product

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

Z-2115-2025

February 27, 2025

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 97018
Status
Completed
Classification
Class II
Quantity
10,000 units
Official record key
device-enforcement:Z-2115-2025

Official wording

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.

Code information: UDI-DI: 15099590224301; Lot Number: 439850

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.