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Terminated

AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA

FDA Recall Z-0165-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Product CodeDFT
Date Initiated2002-07-31
Date Terminated2003-11-26
Product Quantity205 units

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982132BLEASE 6200 ANAESTHESIA VENTILATORBlease Medical Equipment , Ltd. · 1999-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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