Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, the _____ used to ____ in _____, has not been validated, to assure it is...Read More

PRODUCT a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication. Recall #Z-913/914-0. REASON Glucose values greater...Read More