FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
- Recall number
- Z-0399-2022
- Recalling firm
- Beckman Coulter Inc.
- Product
- SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
- Status
- Open, Classified
- Initiated
- 2021-11-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Lot: M106450, UDI: 15099590575113
- 510(k) numbers
- ["K971505"]
- PMA numbers
- not on file
- Product code
- CHH
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28