Wash Kit — Class II medical device recall Z-1149-2018
Terminated recall by Medica Corporation, reported 2018-03-28. The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values wh
| Recall number | Z-1149-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medica Corporation, Bedford, MA, United States |
| Recall initiated | 2017-11-21 |
| Classified | 2018-03-21 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2020-08-20 |
| Quantity | 392 |
| Reason classes | potency |
| Lot numbers | 16279, 17045, 17215 |
| Model numbers | 10680 |
Product
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
Reason for recall
The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
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-1149-2018. 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.