Z-0659-05

Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN...

Name: Z-0659-05 Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN...
Creator: Bio Rad Laboratories, Inc.
Published: 2005-01-25
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2005-01-25 / Terminated

FDA source

Bio Rad Laboratories, Inc. began a recall of 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... on 2005-01-25. The reason FDA records is "New instructions to recommend against using samples with visibly high level of blood". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0659-05
Status: Terminated
Initiated: 2005-01-25
Posted: 2005-03-29
Terminated: 2005-04-21
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: NOM Antigen, Galactomannan, Aspergillus Spp.
Reason for recall: New instructions to recommend against using samples with visibly high level of blood.
FDA root cause: 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
Product codes and lots: 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

Product code NOM

K870176Class IGenetic Systems Rsv Immunofluorescence Test KitGenetic Systems Corp. / cleared 1987-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)