Reported May 15, 2019 · Terminated

Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product…

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?

  • Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry
  • analyzer REF 10680 - Product UsageFor 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
Lot codes and dates
    • Lot #s 18066
    • 18133
    • 18235
    • 18317
Amount recalled
87 kits

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 2, 2020 · Data as of Sep 19, 5:42 PM UTC

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