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/ Manufacturer |
Bio Rad Laboratories, Inc. 6565 185th Ave Ne Redmond WA 98052-5039
|
For Additional Information Contact |
Scott Dennis 425-498-1741
|
Manufacturer Reason for Recall |
New instructions to recommend against using samples with visibly high level of blood.
|
FDA Determined Cause 2 |
Other |
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
|
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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.
|