Recall Z-0908-2010
Bio-Rad Laboratories · initiated August 20, 2008
Product
Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
Codes / lots: Lot F1108
Reason for recall
Elevated optical density (OD) values with the kit Negative Control.
FDA-determined cause: Employee error
Action taken
An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.
Details
- Recall number
- Z-0908-2010
- Initiated
- August 20, 2008
- Posted by FDA
- March 2, 2010
- Terminated
- April 8, 2010
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Quantity
- 82 kits
- Distribution
- Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA