Medica Wash Kit Recalled for Inconsistent Lipase Test Results
Medica Corporation is recalling Wash Kit REF 10680 because an ineffective wash solution causes inconsistent lipase test results.
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 hazard involves diagnostic inaccuracy (inconsistent values) rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving low-risk contamination or functional defects.
Plain-English summary
Medica Corporation has initiated a field recall of the Wash Kit (REF 10680), specifically Lots 16279, 17045, and 17215. The product is a wash solution used with the Medica EasyRA clinical chemistry analyzer. It is applied prior to a lipase (LIP) assay when a triglyceride (TRIG) assay is also part of the work list.
The recall was initiated due to reported inconsistent lipase values when analyzing patient samples. The firm's internal investigation identified the cause as an ineffective wash solution, which results in interference carryover from the triglyceride assay when both tests are run on the same work list.
The affected units were distributed worldwide and in the US. A total of 392 units are involved in this recall. Users of the Medica EasyRA analyzer should check their inventory for these specific lot numbers and stop using the affected wash kits.
The recalled product
- Product
- Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of
- Manufacturer
- Medica Corporation
- Affected units
- 392
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 (2)
- Lots 16279
- 17045 and 17215
Distribution
Distribution scope not specified by the agency.
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