Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1294-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2019-02-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1294-2019
Date of alert: 2019-02-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medica Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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