# FDA recall Z-1149-2018

> **Medica Corporation** · Class II · device recall initiated 2017-11-21.

## 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.

## Distribution

Worldwide and US Distribution.

## Key facts

- **Recall number:** Z-1149-2018
- **Recalling firm:** Medica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-21
- **Report date:** 2018-03-28
- **Termination date:** 2020-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2018

## Citation

> AI Analytics. FDA recall Z-1149-2018. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1149-2018. Source: US FDA. Licensed CC0.

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