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U.S. Department of Health and Human Services

Class 3 Device Recall VARIANT(tm) nbs Sickle Cell Prograin Reorder Pack.

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  Class 3 Device Recall VARIANT(tm) nbs Sickle Cell Prograin Reorder Pack. see related information
Date Initiated by Firm April 14, 2010
Date Posted April 14, 2011
Recall Status1 Terminated 3 on August 08, 2011
Recall Number Z-1984-2011
Recall Event ID 55910
Product Classification Abnormal hemoglobin quantitation - Product Code GKA
Product VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. 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.
Code Information Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210.  Resin Update CD-ROM, 250-3020 lot # CA 00092  Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000;
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jolene Bartilson
510-724-6114
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response Form Questions regarding this recall please call (510) 724-6114.
Quantity in Commerce 658 units
Distribution Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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