Bio Rad Laboratories, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bio Rad Laboratories, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Bio Rad Laboratories, Inc. is recalling Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM due to New instructions to recommend against using samples with visibly high level of blood.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
New instructions to recommend against using samples with visibly high level of blood.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026