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 involves a medical device that may produce inaccurate results masking a deficiency, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling Access Folate Calibrators, Part Number A14207. These calibrators are used to calibrate the Access Folate assay, which is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin), or red blood cells using the Access Immunoassay Systems.
The recall is being conducted because the calibrators may produce falsely elevated results. This issue could mask a folate deficiency, potentially leading to inaccurate clinical assessments of a patient's folate status.
A total of 4,635 units were distributed, with 3,214 units distributed in the United States. The affected lots are 112788, 115741, and 118917. The product was distributed worldwide, including in the United States and numerous other countries. Healthcare facilities and laboratories using these calibrators should stop using the affected units and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells 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# 112788
- 115741
- 118917
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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