LDL cholesterol reagent recalled over increased probability of false high results
Beckman Coulter is recalling 2,932 units of SYNCHRON Systems Direct LDL Cholesterol reagent from one lot because it may generate false high results.
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: falsely high results can misrepresent a patient's condition, and no injuries are reported.
Plain-English summary
The Beckman Coulter SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF 969706, is being recalled.
Beckman Coulter identified an increased probability that reagent lot M404166 may generate false high results. The firm states the issue was discovered internally and confirmed on 19 August 2025.
The recall covers 2,932 units from lot M404166, expiring 30 November 2025, distributed worldwide including in Alabama, Arkansas, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland and Maine. The FDA has classified the action as Class II.
A falsely high LDL result can misrepresent a patient's cardiovascular risk. Laboratories holding lot M404166 should stop using it and follow Beckman Coulter's instructions.
The recalled product
- Product
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,932
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: 969706. Lot: M404166. Expiration Date: 30Nov2025
Distribution
Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- SevereBeckman Coulter Centrifuge Rotors Recalled for Structural Defect
FDA (Devices) · 2026-10-28
- HighBeckman Coulter Optima Ultracentrifuge Rotors Recalled for Structural Defect
FDA (Devices) · 2026-10-28
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
Same hazard · erroneous results
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
Similar recalls
- HighCholesterol Reagent Recalled for Calibration Failures and Erroneous Results
FDA (Devices) · 2021-12-29
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Error Messages
FDA (Devices) · 2013-06-05
- ModerateBeckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference
FDA (Devices) · 2017-05-24
- ModerateBeckman Coulter Recalls Lactate Reagent Due to Calibration Failures
FDA (Devices) · 2013-07-03
- ModerateBeckman Coulter Cholesterol Reagent Recalled for False Low Results
FDA (Devices) · 2016-06-15