May

2011

Cl ll Variant Resin Update CD-ROM

Company:Bio-Rad, Laboratories Inc
Date of Enforcement Report 5/11/2011
Class ll:

PRODUCT
VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only. Recall # Z-1984-2011

REASON
The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.

RECALLING FIRM/MANUFACTURER
Bio-Rad, Laboratories Inc., Hercules CA, by letters on April 14, 2011 and update on May 13, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
658 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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.

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Cl ll Variant Resin Update CD-ROM

Amy Sellers

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