Beckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs
Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is imprecision in test results, which is a functional defect rather than a direct physical injury or contamination risk.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Thyroglobulin Assay reagent packs. The product is used for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. The recall involves 3,035 units in the United States and 7,123 units internationally.
The recall was initiated because some reagent packs may exhibit greater than 10% imprecision at concentrations below 10 ng/mL. This imprecision could affect the accuracy of test results at these specific low concentration levels.
The affected products are identified by Catalogue number 33860 and specific lot numbers: 431990, 434727, 430969, 522896, and 523251. Expiration dates for these lots range from 04/30/17 to 12/31/16. The products were distributed worldwide, including the United States (nationwide including Puerto Rico) and numerous international locations. Users should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
- Manufacturer
- Beckman Coulter Inc.
Distribution
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