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U.S. Department of Health and Human Services

Class 2 Device Recall DiaSorin ETIANA Screen Kit, 96 Test

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  Class 2 Device Recall DiaSorin ETIANA Screen Kit, 96 Test see related information
Date Initiated by Firm March 01, 2010
Date Posted March 02, 2011
Recall Status1 Terminated 3 on March 11, 2011
Recall Number Z-1478-2011
Recall Event ID 55293
510(K)Number k954723  
Product Classification in vitro diagnostic - Product Code LKJ
Product DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
Code Information Model number N0093, manufacture dates 09/17/2009 and 10/12/2009, lot numbers 24592003and 24592035.
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jolene Bartilson
510-724-7000
Manufacturer Reason
for Recall		 Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
Quantity in Commerce 999 kits
Distribution Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
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 = LKJ and Original Applicant = HELIX DIAGNOSTICS, INC.
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