Beckman Coulter Recalls Access Total T4 Calibrators Due to Expiration Date Error
Beckman Coulter is recalling Access Total T4 Calibrators because specific lots do not meet their claimed 12-month expiration date.
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: This is an FDA Class II recall involving a labeling/expiration date discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling Access Immunoassay Systems Total T4 Calibrators, Part Number 33805. The recall affects lots 019818, 021654, and 024072. These calibrators are used to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma, which is used for the diagnosis and confirmation of thyroid disorders.
The recall was initiated because Beckman identified that the affected lots do not meet their 12-month expiration date claim. A total of 6,634 units were distributed, with 2,742 units distributed in the United States and the remainder distributed worldwide to numerous countries including Argentina, Australia, Canada, China, Germany, India, Japan, and the United Kingdom.
Healthcare facilities and laboratories should stop using the affected lots and contact Beckman Coulter for further instructions. Consumers are not directly affected as these products are intended for use in professional medical settings.
The recalled product
- Product
- Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- 019818
- 021654
- 024072
Distribution
Distributed nationwide across the United States.
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