Day

June 22, 1999
6/22/99 Bayer Corporation 3767 units. Class III Technicon SETpoint Chemistry Calibrator. During review of the value assignment procedure it was learned that the operator manually entered intercept corrected SETpoint values into an Excel spreadsheet rather than letting the spreadsheet calculate the corrections from the true SETpoint. The values that were entered were incorrect and, therefore,...
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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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