Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA… — Class II medical device recall Z-1294-2019
Terminated recall by Medica Corporation, reported 2019-05-15, distributed nationwide. Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Li
| Recall number | Z-1294-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medica Corporation, Bedford, MA, United States |
| Recall initiated | 2019-02-06 |
| Classified | 2019-05-07 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2020-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | EE, FR, GT, IN, IQ, IR, KE |
| Quantity | 87 kits |
| Reason classes | potency |
| Lot numbers | 18066, 18133, 18235, 18317 |
| Model numbers | 10680 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1294-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.