Recall Z-0441-2026
Beckman Coulter Inc. · initiated September 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Codes / lots: REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Reason for recall
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
FDA-determined cause: Nonconforming Material/Component
Action taken
Beckman Coulter notified consignees via letter on about 09/17/2025. Consignees were instructed to discontinue use of SYNCHRON Systems LDLD reagent lot M404166 and contact Customer Technical Support Center for assistance, review the Safety Data Sheet (SDS) and discard according to laboratory s Standard Operating Procedures and/or your local regulations. The SDS is available at www.beckmancoulter.com. Additionally, Beckman Coulter recommends sharing the content of this letter with laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from the SYNCHRON Systems LDLD reagent lot M404166 to determine if retesting is necessary.
Details
- Recall number
- Z-0441-2026
- Initiated
- September 17, 2025
- Posted by FDA
- November 6, 2025
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Quantity
- 2,932 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.
- Recalling firm
- Beckman Coulter Inc., Brea, CA