Reported Mar 28, 2018 · Terminated
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF…
Medica Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medica Corporation · 5 Oak Park Dr · Bedford, MA · 01730-1430
Is this the product you have?
- 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 the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
- Lot codes and dates
Lots 1627917045 and 17215
- Amount recalled
- 392
Why it was recalled
The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
This product could cause temporary or reversible health problems — stop using it.
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