FDAFDA · Food and drugs·Recall number Z-1294-2019
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.
Published May 15, 2019 · Recall initiated: February 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medica Corporation
- Distributor
- Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
- Lot
- Lot #s 18066, 18133, 18235, 18317
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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