Z-0441-2026Class II

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Name: Z-0441-2026 SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Creator: Beckman Coulter Inc.
Published: 2025-09-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-09-17 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 on 2025-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0441-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-17
Posted: 2025-11-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Product code: MRR System, Test, Low Density, Lipoprotein
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 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.
Product codes and lots: REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0441-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0441-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-06

Product code MRR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)