Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results
Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.
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: FDA Class II medical device recall of a diagnostic reagent capable of producing erroneous patient test results without currently reported illnesses or injuries. The potential for diagnostic error represents a risk of harm to patients.
Plain-English summary
Beckman Coulter Inc. is recalling 1,433 units of the SYNCHRON Systems Cholesterol (CHOL) Reagent, Lot M106450. The reagent is used in clinical laboratory cholesterol testing.
The affected reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after calibration passes. Brown particulates have been detected in the reagent cartridge. These issues may result in failed calibrations and erroneous low patient cholesterol test results.
The recalled units were distributed nationwide across 39 U.S. states and internationally to India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, and Thailand.
The recalled product
- Product
- SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 1,433
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 (2)
- Lot: M106450
- UDI: 15099590575113
Distribution
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
Same hazard · calibration failure
See all →- ModeratePhosphorus reagent lots recalled because calibration may fail before expiration date
FDA (Devices) · 2025-10-15
- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- ModerateBeckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error
FDA (Devices) · 2025-05-21
Similar recalls
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Calibration Failures
FDA (Devices) · 2013-07-03
- HighLDL cholesterol reagent recalled over increased probability of false high results
FDA (Devices) · 2025-11-12
- ModerateBeckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference
FDA (Devices) · 2017-05-24
- LowBeckman Coulter Recalls Synchron Multi Calibrator Diskettes Due to Mislabeling
FDA (Devices) · 2012-10-31
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Error Messages
FDA (Devices) · 2013-06-05
- HighBeckman Coulter Bicarbonate Reagent Recalled for Potential Calibration Failures
FDA (Devices) · 2023-05-24