Clinical Chemistry Immunoglobulin M, List Number 1E01-20
FDA device recall Z-0384-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Reason for recall
- These specific protein assays are not meeting the 57-day on board stability claim
- Action taken
- A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
- Root cause
- Other
- Status
- Terminated
- Product code
- DFT
- Quantity affected
- 1275 (212 in US)
- Distribution
- Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand
- Date initiated
- 2005-11-10
- Date posted
- 2006-01-11
- Date terminated
- 2007-03-20
- 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 |
|---|---|---|
| IGM (K983132) | Abbott Laboratories | 1998-11-04 |