Z-1294-2019 Class II Terminated
FDA device recall Z-1294-2019 was initiated by Medica Corporation on February 6, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 2, 2020). Affected quantity: 87 kits.
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