Class II — Medica Corporation
| Recalling firm | MEDICA CORP. |
|---|---|
| Registered facility | MEDICA CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 87 kits |
| Distribution | Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA. |
| Initiated | 2019-02-06 |
| Classified | 2019-05-07 |
| Terminated | 2020-10-02 |
| Recall number | Z-1294-2019 |
| Initiation | Voluntary: 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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