LDL cholesterol assays recalled over triglyceride interference causing biased results
Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the assay may return positively biased results outside its performance claim, and no injuries are reported.
Plain-English summary
The LDL-Cholesterol assay, REF OSR6196 and OSR6296, is being recalled by Beckman Coulter Ireland, Inc. The enforcement record sets out the assay's two-phase chemistry in full.
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use. The record states the LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL, which may cause a maximum positive bias of up to 28.8% in low LDL cholesterol samples at a concentration of 80 mg/dL, and up to 11.02% in high LDL cholesterol samples at a concentration of 160 mg/dL.
The record lists 34,451 units under REF/UDI-DI OSR6196/15099590010928 and OSR6296/15099590020361, all lots and expiration dates. Distribution covered a wide range of US states and, outside the US, Brazil, South Africa, Argentina and other countries listed in the record. The FDA has classified the action as Class II.
A positively biased cholesterol result can misstate a patient's lipid level. The enforcement record reports no injuries. Laboratories should follow Beckman Coulter's instructions.
The recalled product
- Product
- The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a…
- Manufacturer
- Beckman Coulter Ireland, Inc.
- Affected units
- 34,451
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)
- REF/UDI-DI: OSR6196/15099590010928
Distribution
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