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U.S. Department of Health and Human Services

Class 2 Device Recall ETIABAUK PLUS

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  Class 2 Device Recall ETIABAUK PLUS see related information
Date Initiated by Firm August 19, 2010
Date Posted March 22, 2011
Recall Status1 Terminated 3 on August 16, 2012
Recall Number Z-1744-2011
Recall Event ID 57937
PMA Number P990042 
Product Classification Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Product ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285

In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
Code Information lot numbers 0650270A and 0650270A/1.
Recalling Firm/
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
Manufacturer Reason
for Recall
Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co
FDA Determined
Cause 2
Action The firm, DiaSorin, sent a "Customer Notification Letter" dated 19 August, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to destroy all remaining inventory and complete and return the receipt of notification and destruction of product form, found in the bottom portion of the letter, via fax to: (651) 351-5669, ATTN: TECHNICAL SERVICES or mail to: ATTN: TECHNICAL SERVICES, 1951 Northwestern Ave., Stillwater, Minnesota 55082-0285. If you have any questions or concerns, please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.
Quantity in Commerce 710
Distribution Worldwide distribution: USA including states of: AL, AR, CA, CT, DE, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK OR, PA, TX, VT, VA, WA,and WI; and country of: SOUTH KOREA.
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.
PMA Database PMAs with Product Code = LOM and Original Applicant = DIASORIN, INC.