SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Summary
The FDA issued a Class II for SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 by Beckman Coulter Inc.. Reason: Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 ma.
Details
Source
Device Recall
External ID
Z-0441-2026
Action Date
2025-11-12
Status
Ongoing
Category
device
Product Description
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Lot/Code Info: REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Quantity Affected: 2,932 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-17
Company
Brea, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0441-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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