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Beckman Coulter Inc. Recall 89035

Description: SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Beckman Coulter Inc. Recall 89035 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0399-2022
Event ID89035
Event DescriptionSYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Product TypeDevices
DistributionUS 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
Recall ReasonCholesterol 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.
Device Classification20211229
Device Code InfoLot: M106450, UDI: 15099590575113
Center Classification Date20211220
Recall Initiation Date20211110
Recalling FirmBeckman Coulter Inc.
Initial Notification Letter
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