Home / Recalls / Medica Corporation / Z-1294-2019

Z-1294-2019 Class II Terminated

Recalled by Medica Corporation — Bedford, MA

Recall Details

Product Type: Devices
Report Date: May 15, 2019
Initiation Date: February 6, 2019
Termination Date: October 2, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 87 kits

Product Description

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.

Distribution Pattern

Worldwide distribution - US Nationwide and countries of IRAQ, FRANCE, INDIA, GEORGIA, GEORGIA, FRANCE GUATEMALA, KENYA, IRAN, ESTONIA.

Code Information

Lot #s 18066, 18133, 18235, 18317