AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA
FDA device recall Z-0165-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DFT
- Quantity affected
- 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, Ar
- Date initiated
- 2002-07-31
- Date posted
- 2004-07-20
- Date terminated
- 2003-11-26
- Location
- South Pasadena, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLEASE 6200 ANAESTHESIA VENTILATOR (K982132) | Blease Medical Equipment , Ltd. | 1999-04-15 |