Raichem Cobas Mira Class III

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, CA.

RECALLED BY:

Roche Diagnostics Corporation, Indianapolis, IN., by letter, on December
20, 2000. Firm initiated recall ongoing.

DISTRIBUTION:

Nationwide.

QUANTITY:

2550 pieces.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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:  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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