Beckman Coulter Bicarbonate Reagent Worldwide Recall Due to Calibration Failure Potential
Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.
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 recall of a clinical laboratory reagent with potential for calibration and quality control failures. No illnesses, injuries, or actual failures have been reported; the risk is theoretical, making this a risk-of-harm product where injury has not yet been reported, which qualifies as severity score 3 per the rubric.
Plain-English summary
Beckman Coulter Inc. is recalling Bicarbonate reagent (REF: OSR6137, 4x25 mL) distributed worldwide. Approximately 48,633 units are affected by this recall.
The reagent has the potential to decrease in optical density (OD) values, which could result in calibration failures and quality control failures. This could impact the accuracy of laboratory test results.
The recalled product was distributed nationally across all U.S. states, U.S. territories (Guam and Puerto Rico), and internationally to Brazil, Canada, Mexico, Panama, and Taiwan.
Laboratories and healthcare facilities using this reagent should discontinue use and contact Beckman Coulter for instructions on product replacement or other corrective measures. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- calibration-failure
- quality-control-failure
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 (1)
- All Lots: UDI-GI: 15099590020187
Distribution
Distributed nationwide across the United States.
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