Medica Wash1 Solution Recalled for Ineffective Probe Cleaning
Medica Corporation is recalling Wash1 solution because it fails to clean the probe effectively, potentially causing test interference on the EasyRA analyzer.
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, fitting the criteria for a moderate severity score.
Plain-English summary
Medica Corporation is recalling 87 kits of Wash1 solution, a wash solution used prior to the Lipase assay on the EasyRA clinical chemistry analyzer. The product is identified by reference number 10680 and is used to wash the probe of the Medica EasyRA Chemistry Analyzer to prevent interference between certain tests.
The recall was initiated because the Wash1 solution is ineffective in cleaning the dispensing probe of TRIG and LDL reagents. This failure can lead to interference with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
The affected lots are 18066, 18133, 18235, and 18317. The product was distributed worldwide, including in the United States, Iraq, France, India, Georgia, Guatemala, Kenya, Iran, and Estonia. Users of the EasyRA analyzer should stop using the affected Wash1 solution and contact Medica Corporation for further instructions.
The recalled product
- Product
- Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
- Manufacturer
- Medica Corporation
- Hazard
- Affected units
- 87
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 (4)
- Lot #s 18066
- 18133
- 18235
- 18317
Distribution
Distributed nationwide across the United States.
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