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U.S. Department of Health and Human Services

Class 2 Device Recall BioRad

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  Class 2 Device Recall BioRad see related information
Date Initiated by Firm January 25, 2005
Date Posted March 29, 2005
Recall Status1 Terminated 3 on April 21, 2005
Recall Number Z-0659-05
Recall Event ID 31123
510(K)Number K870176  
Product Classification Antigen, Galactomannan, Aspergillus Spp. - Product Code NOM
Product Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.
Code Information Lot # & Expiration dates: 1L044 3/31/03; 2C047 7/31/03; 2H049 9/30/03; 2L050 9/30/03; 2M051 9/30/03; 2M052 11/30/03; 3D053 10/31/04; 3H0055 10/31/04; 3K0054 10/31/04; 4A0056 7/5/2005
Recalling Firm/
Bio Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact Scott Dennis
Manufacturer Reason
for Recall
New instructions to recommend against using samples with visibly high level of blood.
FDA Determined
Cause 2
Action Letters were sent to customers January 25-27, 2005 via overnight mail. Letters advised the customers of the issue and included a new package insert. The firm included a revised package insert to clarify precautions. The firm sent a CORRECTED COPY letter dated January 31, 2005 outlining the changes made in the product insert.
Quantity in Commerce 1547 kits
Distribution Product was distributed to 93 hospitals and medical centers located throughout the US
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 = NOM and Original Applicant = GENETIC SYSTEMS CORP.