Beckman Coulter Recalls Access hLH Calibrators Due to Stability Test Failures
Beckman Coulter is recalling Access hLH Calibrators because stability testing failed to verify expiration dating. The affected lots did not meet procedural requirements for shelf-life.
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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to the failure of stability testing to verify expiration dating, which fits the criteria for a moderate severity recall involving procedural or quality control issues without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling specific lots of the Access hLH Calibrator. This product is a medical device used to calibrate the Access hLH assay, which measures luteinizing hormone (LH) levels in human serum and plasma.
The recall was initiated because real-time stability testing for certain lots failed at the 13-month and 14-month time points. According to Beckman Coulter's procedures, one additional month of testing is required beyond the claimed expiration period to verify expiration dating. Consequently, these lots did not meet the company's procedural requirements for a 12-month shelf-life.
The recall affects 14,409 units distributed worldwide, including the United States and numerous other countries. Affected lot numbers are 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, and 916872. Users should check their inventory for these specific lot numbers and contact Beckman Coulter for further instructions.
The recalled product
- Product
- The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 14,409
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 (10)
- Lots: 220438
- 122157
- 118299
- 113689
- 109784
- 022519
- 014099
- 011895
- 008546
- 916872
Distribution
Distributed nationwide across the United States.
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