Lower riskMedical device recall · FDA · Published February 27, 2025
Beckman Coulter Access Vitamin B12 Reagent Lot 439850 May Cause Erroneous Results
Beckman Coulter recalls Access Vitamin B12 Reagent lot 439850 due to potential erroneous Vitamin B12 results, which could lead to delayed or improper diagnosis. Affected units may need replacement.
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.
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Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter Access Vitamin B12 Reagent Lot 439850 May Cause Erroneous Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52734-beckman-coulter-access-vitamin-b12-reagent-lot-439850-may-cause. Based on FDA recall #Z-2115-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2115-2025%22&limit=1).
The FDA announced on Feb. 27, 2025, that Beckman Coulter is recalling Access Vitamin B12 Reagent due to a hazard of erroneous test results. The agency issued the Class II recall for lot 439850 distributed internationally.
How to tell if you have it
Brand: Beckman Coulter
Product: Access Vitamin B12 Reagent
Catalog Number: 33000
Lot Number: 439850
UDI-DI: 15099590224301
The hazard
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.
Context
GovInfoNow's records show Beckman Coulter has 132 other recalls on record since June 20, 2017. Recent brand recalls include the Beckman Coulter DxC 500i Modules with Software 1.5 (July 15, 2026) and the Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026). Other recent recalls of similar products include the Beckman Coulter Bicarbonate Reagent recall (Oct. 14, 2025), the Beckman Coulter AU5800 Chemistry Analyzer recall (Jan. 30, 2026), and the Beckman Coulter DxC 700 AU recall (Jan. 30, 2026).
How to tell if you have this one
Check the lot number on the reagent bottle. The affected lot is 439850. This reagent is sold under catalog number 33000.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Number
Look for the lot number 439850 on the reagent bottle to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2115-2025 (February 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2115-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.