March 21, 2001
Company: Ortho-Clinical Diagnostics, Inc.Date of Enforcement Report: 3/21/01 Date of recall letter: 6/26/00 Class: II PRODUCT: a) Vitros 250 and Vitros 250 AT Chemistry Systems Software version below 7.0.; Recall #Z-386-1. b) Vitros 950 and Vitros 950AT Chemistry Systems with software version below 3.07. Recall #Z-387-1. REASON: The Bilirubin (Unconjugated Bilirubin) results may be reported...
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What’s New

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:

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