Z-0399-2022Class II

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Name: Z-0399-2022 SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Creator: Beckman Coulter Inc.
Published: 2021-11-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-11-10 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 on 2021-11-10. FDA classified it as Class II and gives the reason as "Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in...". 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-0399-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-10
Posted: 2021-12-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 11/10/21 recall notices were sent to customers. Customers with questions are encouraged to contact the Customer Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers were asked to take the following action: 1) Discontinue use of affected cholesterol reagent and follow the product replacement instructions. 2) Review the Safety Data Sheet (SDS) and discard according to your laboratory s Standard Operating Procedures and/or your local regulations. 3) Retrospective review is left to the discretion of the Laboratory Director. 4) Share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 5) Complete and return the Response Form. For customers in the United States, if you need replacement product, complete the Replacement Order Form.
Quantity in commerce: 1433
Distribution: US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas, Washington, New Mexico, Iowa ,Nebraska, Idaho, Michigan, Maryland, Arizona, Hawaii, Missouri, Oregon, Mississippi, Rhode Island, Alaska, Tennessee, Illinois, Delaware, Kentucky, Arkansas, West Virginia, Massachusetts. OUS: India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, Thailand
Product codes and lots: Lot: M106450, UDI: 15099590575113

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0399-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0399-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-20

Product code CHH

K971505Class ISynchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. / cleared 1997-06-11

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)