Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Reported: July 23, 2025 Initiated: February 27, 2025 #Z-2115-2025
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 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
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850. Recalled by Beckman Coulter, Inc.. Units affected: 10,000 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 23, 2025. Severity: Moderate. Recall number: Z-2115-2025.
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