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 colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
USThe 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 colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Recalling Firm: Beckman Coulter Ireland, Inc.
Reason for Recall / Hazard
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
Product Description & Identification
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 colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Affected Products
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 colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Additional Source Details
| Field | Value |
|---|---|
| City | O'Callaghan'S Mills |
| Event id | 98094 |
| Address 1 | Lismeehan |
| Code info | REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361. All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior. |
| Postal code | N/A |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 34,451 |
| Reason for recall | Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251208 |
| Initial firm notification | Letter |
| Center classification date | 20260121 |
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Overview
- Recalling FirmBeckman Coulter Ireland, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT, OK, NY, AZ, LA, OR, AL, MO, IN, IL, KY, MS, NH, AK, SD, MN, TN, PR, MI, IA, WI, WV, ME, SC, HI, RI, ND, NE, ID, AR, WY, DC, GU, DE, CT. OUS: Brazil, South Africa, Argentina, Mexico, Canada, Costa Rica, Peru, El Salvador, Ecuador, Panama, Singapore, Ireland, United Kingdom of Great Britain and Northern Ireland, Germany, China, Korea, Republic of
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🚨 SAFETY ALERT: Beckman Coulter Ireland, Inc. - 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 colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample. Check if your household is affected: https://therecallfile.com/recalls/the-ldl-cholesterol-assay-is-comprised-of-two-distinct-phases-in-phase/FDA-Z-1135-2026
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