Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results
Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (masking a medical deficiency) where specific injury or illness reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling Access Folate WHO Calibrators, Part Number A98033. These calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.
The recall is being conducted because the product may produce falsely elevated results, which could mask a folate deficiency. The affected units include Lot numbers 122651, 123635, and 219962.
A total of 5,266 units were distributed, with 3,214 units distributed in the United States. The product was distributed nationwide in the US and to numerous countries worldwide. Users should stop using the affected calibrators and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
- Manufacturer
- Beckman Coulter Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# 122651
- 123635
- 219962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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