FDA Medical devices recall ·
Access Vitamin B12 Reagent recall
- Recall number
- Z-2115-2025
- Date
- (initiated February 27, 2025)
- Company / brand
- Beckman Coulter, Inc.
1000 Lake Hazeltine Dr, Chaska, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 10,000 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 15099590224301; Lot Number: 439850
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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2115-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.