Alfa Wassermann System Diluent Recalled for Inaccurate Calibration Results
Alfa Wassermann is recalling 4,104 kits of System Diluent because inorganic phosphorus assays may not produce acceptable calibration 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: 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 potential inaccurate calibration results, which fits the criteria for a moderate severity recall involving a quality defect without reported harm.
Plain-English summary
Alfa Wassermann, Inc. is recalling 4,104 kits of Alfa Wassermann System Diluent 750 mL, Lot 155599. The product is a water solution intended to dilute reagents and rinse parts of a clinical chemistry instrument. The recall was initiated because inorganic phosphorus assays using this specific lot may not produce acceptable calibration results.
The affected product was distributed nationwide in the United States, as well as in Canada and the Cayman Islands. The source text does not specify the exact number of units distributed in each region or the specific dates of distribution.
Consumers and healthcare facilities should stop using the affected lot of System Diluent and contact Alfa Wassermann, Inc. for further instructions or a replacement.
The recalled product
- Product
- Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute…
- Manufacturer
- Alfa Wassermann, Inc.
- Hazard
- Affected units
- 4,104
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)
- Lot Number 155599
Distribution
Distributed nationwide across the United States.
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