Access Vitamin B12 Reagent recall
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Why was Access Vitamin B12 Reagent 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 I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 15099590224301; Lot Number: 439850
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Recalling firm
- Beckman Coulter, Inc.
- 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
- Recall date
- July 23, 2025
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)