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.
FDA Recall Z-0659-05 · Posted 2005-03-29
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Recalling FirmBio Rad Laboratories, Inc.
Recall StatusTerminated
Product CodeNOM
Date Initiated2005-01-25
Date Terminated2005-04-21
Product Quantity1547 kits
Reason for Recall
New instructions to recommend against using samples with visibly high level of blood.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to 93 hospitals and medical centers located throughout the US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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