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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent

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 Class 2 Device Recall SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagentsee related information
Date Initiated by FirmSeptember 17, 2025
Date PostedNovember 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0441-2026
Recall Event ID 97628
Product Classification System, test, low density, lipoprotein - Product Code MRR
ProductSYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Code Information REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactIan Pilcher
443-350-6459
Manufacturer 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 2		Nonconforming Material/Component
ActionBeckman 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.
Quantity in Commerce2,932 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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