Day

June 14, 1996
CIBA Corning Acs:180 and ACS:180 Plus Analyzers, used to conduct various laboratory diagnostictests. Recall #Z-368-9. REASON Due to a software error, the ACS Folate and ACS T-Uptake assays may run without the required conditioning solution. As a result, the test results may be outside of the system requirements. CODE All serial numbers for the ACS...
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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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