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.
What this means for you
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
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · imprecision
See all →- HighAccess Total T4 thyroxine assay recalled for test imprecision
FDA (Devices) · 2024-03-27
- HighSiemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
FDA (Devices) · 2022-04-06
- HighDiagnostic thromboplastin reagent recalled due to performance issues
FDA (Devices) · 2021-12-01
- ModerateRandox Lipase Assay Substrate Recalled for Imprecision in Quality Control
FDA (Devices) · 2020-08-12
- ModerateRandox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples
FDA (Devices) · 2020-08-12