January 31, 2001
Company: Raichem Date of enforcement report: 1/31/01 Date of recall: 12/20/00 PRODUCT: Roche Creatinine Mira, Catalog No.3033414. Recall #Z-071-1. REASON: Package insert, contained in the kit, was printed with an incorrect reagent volume for COBAS MIRA analyzers using software Version 8735. CODE: Lot No. A12071, Exp. September 2002. MANUFACTURER: Raichem, division of Hemagen, San Diego,...
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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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