SYNCHRON Phosphorus Chemistry Reagent Lots Fail Calibration Before Expiration
Specific SYNCHRON Systems Phosphorus (PHOSm) reagent lots may fail calibration before expiration, delaying patient test results. Beckman Coulter is recalling 2,146 units distributed across multiple states and countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification with no reported illnesses or injuries reported. The hazard is a functional failure (calibration) that delays patient results without direct reported harm, consistent with a precautionary moderate-risk recall.
Plain-English summary
Beckman Coulter Inc. is recalling specific lots of SYNCHRON Systems Phosphorus (PHOSm) Reagent (REF 467868), an in vitro diagnostic reagent used in automated chemistry analyzer systems. The recall affects 2,146 units.
Certain lots of the reagent may fail calibration before the lot expiration date. When calibration fails, test results are delayed.
The affected product was distributed to healthcare facilities in the United States (Alabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington, and West Virginia) and internationally to Canada, Mexico, and Singapore. Affected lot numbers include M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466, M410513, and M412278.
The recalled product
- Product
- SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- calibration-failure
Distribution
Distributed in 15 states:
- AL
- KY
- LA
- MA
- MD
- MS
- NC
- NE
- NJ
- NY
- OK
- PA
- TX
- WA
- WV
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