Medica

3 recalls •

• Categories: Diagnostic Equipment, Other Medical Devices, Infusion Pumps

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.

Class I - Dangerous

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.

Feb 6, 2019 Diagnostic Equipment Nationwide View Details →

EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

Class I - Dangerous

Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

Apr 11, 2017 Other Medical Devices View Details →

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.

Class I - Dangerous

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.

Nov 21, 2017 Infusion Pumps View Details →