Clinical Chemistry Apolipoprotein A1, List Number 9D92-20
This recall has been terminated (originally issued January 11, 2006).
- Recall Initiated
- November 10, 2005
- Posted
- January 11, 2006
- Terminated
- March 20, 2007
- Recall Number
- Z-0383-06
- Quantity
- 617 (134 in US)
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
Reason for Recall
These specific protein assays are not meeting the 57-day on board stability claim
Distribution
Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand
Lot / Code Info
Lot Number(s): 30029HW00, 28002HW00, 26027HW00, & 23006HW00
Root Cause
Other
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..