Official recall record
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-02-27
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590224301
- Brand on record
- Beckman Coulter, Inc.
- Product category
- Medical Device
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-03-16 · US FDA — Medical Devices
Access Total T4 Calibrator, Catalog No. 33805 - 2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin S
All 32 official recall notices naming Beckman Coulter, Inc. on this site →
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