Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays due to higher imprecision and outliers on Beckman Coulter AU Systems.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to analytical imprecision (outliers), which fits the criteria for a moderate severity score involving low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,979 cartons of Emit 2000 Phenobarbital Assay (OSR4D229) and Syva Emit Phenobarbital Assay (4D019UL). These homogeneous enzyme immunoassays are intended for the quantitative analysis of Phenobarbital in human serum or plasma.
The recall is due to confirmed higher imprecision in the recalled lots when used on Beckman Coulter AU Systems. The firm found that within-run imprecision resulted in a frequency of outliers that differ from the expected value by 20%. This recall is an expansion of a previous action.
The affected lots are Emit 2000 Phenobarbital Assay lots 1237 and 1264, and Syva Emit Phenobarbital Assay lots E1, E2, and E3. The products were distributed in California, Florida, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Mississippi, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, and Washington. Users should stop using these specific lots and contact the manufacturer for instructions.
The recalled product
- Product
- Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,979
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 (3)
- lots E1
- E2
- and E3.
Distribution
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