Z-2115-2025 Class II
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2025
- Initiation Date
- February 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,000 units
Product Description
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Reason for Recall
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.
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
Code Information
UDI-DI: 15099590224301; Lot Number: 439850