Beckman Coulter Inc. Recall 89035
Description: SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Beckman Coulter Inc. Recall 89035 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0399-2022 |
| Event ID | 89035 |
| Event Description | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 |
| Product Type | Devices |
| 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 |
| Quantity | 1433 |
| Recall 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. |
| Device Classification | 20211229 |
| Device Code Info | Lot: M106450, UDI: 15099590575113 |
| Center Classification Date | 20211220 |
| Recall Initiation Date | 20211110 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Letter |
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