Phosphorus reagent lots recalled because calibration may fail before expiration date
Beckman Coulter is recalling 2,146 units of SYNCHRON Systems Phosphorus reagent because specific lots may fail calibration before the lot expiration date, delaying patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 because the stated consequence is a delay in obtaining patient results rather than an erroneous result, with no injury reported.
Plain-English summary
SYNCHRON Systems Phosphorus (PHOSm) Reagent, REF 467868, for in vitro diagnostic use, is being recalled.
Specific SYNCHRON Systems Modular Chemistry Phosphorus reagent lots may fail calibration before the lot expiration date, which causes a delay in obtaining patient results.
The recall covers 2,146 units carrying UDI 15099590233358, across lots including M309642, M309641, M401490, M404365, M406380, M406417, M408408, M410466 and M410513. Distribution covered Alabama, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington and West Virginia, plus Canada, Mexico and Singapore. The FDA has classified the action as Class II.
The enforcement record describes a delay rather than an incorrect result. Laboratories holding affected lots should follow Beckman Coulter's instructions.
The recalled product
- Product
- SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,146
Distribution
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