—#190353

Product

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

FDA product code: CHH — Enzymatic Esterase--Oxidase, Cholesterol
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K971505
Affected lot / code info: Lot: M106450, UDI: 15099590575113

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2021-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190353. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.