Class 2 Device Recall DiaSorin ETIANA Screen Kit, 96 Test

• Date Initiated by Firm: March 01, 2010
• Date Posted: March 02, 2011
• Recall Status: Terminated 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: 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