AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- July 31, 2002
- Posted
- July 20, 2004
- Terminated
- November 26, 2003
- Recall Number
- Z-0165-04
- Quantity
- 205 units
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.
Distribution
Nationwide to the following states: Texas, Illinois, Indiana, Tennessee, Alaska, Pennsylvania, New York, Florida, Massachusetts, Missouri, Alabama, North Carolina, California, Ohio, Utah, Michigan, Arizona, Wisconsin, Oklahoma, Maine, Kansas, Georgia, Mississippi, Connecticut, Rhode Island, Washington, Wyoming, Louisiana, Washington, Maryland, New Jersey, Arkansas, Iowa, South Carolina, Colorado, Minnesota, North Dakota, and West Virginia. Worldwide to the following countries: Argentina, Australia, Brazil, Germany, England, Canada, Chile, Colombia, Dominican Republic, Denmark, France, Hong Kong, Japan, Korea, Singapore, Guatemala, New Zealand, Thailand, Turkey, Spain, Italy, South Africa, Sweden, Greece, Portugal, Venezuela, Pakistan, Finland, Ireland, and Taiwan.
Lot / Code Info
All lots
Root Cause
Other
Action Taken
Consignees were provided with assay parameters for the RCD flag which may enhance the detection of these type of specimens. The assay parameter settings for the RCD flag were distributed to all AEROSET consignees in the United States by direct mail and to country managers worldwide via a Product Information letter dated July 31, 2002. Also provided with the Product Information letter was an AEROSET IgM Application Sheet containing the updated assay parameters for the RCD flag.