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Class 3 Device Recall Clinical Chemistry Prealbumin, List Number 1E0220 |
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| Date Initiated by Firm |
November 10, 2005 |
| Date Posted |
January 11, 2006 |
| Recall Status1 |
Terminated 3 on March 20, 2007 |
| Recall Number |
Z-0385-06 |
| Recall Event ID |
34281 |
| Product Classification |
Prealbumin, Antigen, Antiserum, Control - Product Code JZJ
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| Product |
Clinical Chemistry Prealbumin, List Number 1E02-20 |
| Code Information |
Lot Number(s): 32063HW00, 27019HW00, & 23044HW00 |
Recalling Firm/
Manufacturer |
Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
|
| For Additional Information Contact |
Mark Littlefield
972-518-6062
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Manufacturer Reason
for Recall |
These specific protein assays are not meeting the 57-day on board stability claim
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FDA Determined
Cause 2 |
Other |
| Action |
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.. |
| Quantity in Commerce |
734 (568 in US) |
| Distribution |
Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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