BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).
This recall has been terminated (originally issued June 11, 2008).
- Company
- Bio-Rad Laboratories
- Recall Initiated
- November 13, 2007
- Posted
- June 11, 2008
- Terminated
- May 23, 2011
- Recall Number
- Z-1157-2008
- Quantity
- 1,020 kits
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
False negative results due to reagent packs exhibiting low signal.
Distribution
Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
Lot / Code Info
Lot Numbers: 943710 Exp. 7/30/07 and 943711 Exp. 4/30/08
Root Cause
Nonconforming Material/Component
Action Taken
On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.