CLASS II Device recall · Reported 23 Jul 2025 · FDA Enforcement Report
Access Vitamin B12 Reagent recalled by Beckman Coulter
Beckman Coulter is recalling Access Vitamin B12 Reagent. The recall was initiated on 27 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2115-2025
- FDA event ID
- 97018
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 27 Feb 2025
- FDA classified
- 11 Jul 2025
- Reported
- 23 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Feb 2025 | Recall initiated by company | |
| 11 Jul 2025 | Classified by FDA | +134 days |
| 23 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Where it was distributed
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
Questions about this recall
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.
Which lots are affected?
UDI-DI: 15099590224301; Lot Number: 439850
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beckman Coulter
All 336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled | Beckman Coulter | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |