Recall Z-0165-04 ยท DFT Igm, Antigen, Antiserum, Control
Abbott Laboratories Diagnostic Div
AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA
| Date | Jul 20, 2004 (initiated Jul 31, 2002) |
| Status | Terminated |
| Reason | Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies. |
| Root cause | Other |
| 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. |
| Quantity | 205 units |
| 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, Washing |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982132 | BLEASE 6200 ANAESTHESIA VENTILATOR Blease Medical Equipment , Ltd., Apr 15, 1999 |