RegWardenFDA facility compliance records
Recall

Class II — Medica Corporation

Recalling firmMEDICA CORP.
Registered facilityMEDICA CORP. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonWash1 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.
ProductMedica 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.
Quantity87 kits
DistributionWorldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.
Initiated2019-02-06
Classified2019-05-07
Terminated2020-10-02
Recall numberZ-1294-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Medica Corporation (Z-1294-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82217/

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