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U.S. Department of Health and Human Services

Class 2 Device Recall VARIANT Sickle Cell Short Program

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  Class 2 Device Recall VARIANT Sickle Cell Short Program see related information
Date Initiated by Firm April 22, 2010
Date Posted March 29, 2011
Recall Status1 Terminated 3 on April 07, 2011
Recall Number Z-1846-2011
Recall Event ID 55905
510(K)Number K924813  
Product Classification Abnormal hemoglobin quantitation - Product Code GKA
Product The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA

The VARIANT Sickle Cell Short Program is designed 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. For in vitro diagnostic use.
Code Information Catalog number 270-0500, lot numbers 70000349, 70000353, both with expiration dates of 6/30/2011, which contains ROM Card Lot # LA82418 (Catalog # 270-0507). Rom Card is included in kit Lot number 70000349 and 70000353.
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jolene Bartilson
Manufacturer Reason
for Recall
The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.
FDA Determined
Cause 2
Action The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated April 22, 2010, to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and quarantine the product; complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE FORM via fax to: (510) 741-3954, Attn: Bio-Rad CSD Regulatory Affairs, and contact there regional Bio-Rad office for ROM Card replacement. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.
Quantity in Commerce 10 units
Distribution Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.
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.
510(K) Database 510(K)s with Product Code = GKA and Original Applicant = BIO-RAD