Recall Z-1294-2019— Medica Corporation
Class II · Terminated
Class II FDA medical device recall by Medica Corporation, initiated 2019-02-06, terminated 2020-10-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Medica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-06
- Terminated
- 2020-10-02
- Firm location
- Bedford, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.