Beckman Coulter Recalls Access Ostase QC for Expiration Date Issues
Beckman Coulter is recalling Access Ostase QC kits because they do not meet expiration date claims within 10% criteria.
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, but the specific defect is 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 the Access Ostase QC, Catalog No. 37309, B83877. The product is intended for monitoring system performance of the Access Ostase assay.
The recall was initiated because the company determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. A total of 625 kits are affected, with 113 kits distributed in the United States.
The affected lots are identified by codes 628297, 623207, and 626001. Distribution in the US included nationwide coverage in specific states, and the product was also distributed to various international locations including Belgium, Canada, China, and others. Users should stop using the affected lots and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
- 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 (1)
- 628297 623207 626001
Distribution
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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