Beckman Coulter Recalls Access Ostase Calibrators for Expiration Date Issues
Beckman Coulter is recalling Access Ostase Calibrators 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. The hazard involves expiration date claims not meeting criteria, which is a labeling/quality issue without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Beckman Coulter Inc. is recalling Access Ostase Calibrators, Catalog No. 37305, B83876. The company determined that these calibrators and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
The affected product is intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma. A total of 357 kits were distributed, with 94 kits distributed in the United States.
The recall affects distribution in the US states of UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL, as well as numerous international locations including Belgium, Canada, China, and others. Affected lot codes include 623207, 626000, 628294, and 628296.
The recalled product
- Product
- Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access…
- 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)
- 623207 626000 628294 628296
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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