Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results
Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall of a diagnostic reagent capable of producing erroneous patient test results without currently reported illnesses or injuries. The potential for diagnostic error represents a risk of harm to patients.
Plain-English summary
Beckman Coulter Inc. is recalling 1,433 units of the SYNCHRON Systems Cholesterol (CHOL) Reagent, Lot M106450. The reagent is used in clinical laboratory cholesterol testing.
The affected 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 calibration passes. Brown particulates have been detected in the reagent cartridge. These issues may result in failed calibrations and erroneous low patient cholesterol test results.
The recalled units were distributed nationwide across 39 U.S. states and internationally to India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, and Thailand.
The recalled product
- Product
- SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- calibration-failure
- quality-control-failure
- product-contamination
- erroneous-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: M106450
- UDI: 15099590575113
Distribution
Distributed nationwide across the United States.
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