Abbott Laboratories Diagnostic Div Clinical Chemistry Immunoglobulin M, List Number 1E01-20 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clinical Chemistry Immunoglobulin M, List Number 1E01-20
Brand
Abbott Laboratories Diagnostic Div
Lot Codes / Batch Numbers
Lot Number(s): 30067HW00, 27057HW00, & 23026HW00
Products Sold
Lot Number(s): 30067HW00, 27057HW00, & 23026HW00
Abbott Laboratories Diagnostic Div is recalling Clinical Chemistry Immunoglobulin M, List Number 1E01-20 due to These specific protein assays are not meeting the 57-day on board stability claim. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
These specific protein assays are not meeting the 57-day on board stability claim
Recommended Action
Per FDA guidance
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..
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026