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.
This recall has been terminated (originally issued March 29, 2005).
- Company
- Bio-Rad Laboratories, Inc
- Recall Initiated
- January 25, 2005
- Posted
- March 29, 2005
- Terminated
- April 21, 2005
- Recall Number
- Z-0659-05
- Quantity
- 1547 kits
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
New instructions to recommend against using samples with visibly high level of blood.
Distribution
Product was distributed to 93 hospitals and medical centers located throughout the US
Lot / Code Info
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
Root Cause
Other
Action Taken
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.