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Recall Observatory FDA recall evidence

Device 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.

Z-1294-2019

February 06, 2019

Class II

Product summary

Firm
Medica Corporation
Event
Event 82217
Status
Terminated
Classification
Class II
Quantity
87 kits
Official record key
device-enforcement:Z-1294-2019

Official wording

Reason: 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.

Code information: Lot #s 18066, 18133, 18235, 18317

Distribution pattern: Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.