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Terminated

Clinical Chemistry Immunoglobulin M, List Number 1E01-20

FDA Recall Z-0384-06 · Posted 2006-01-11

Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Product CodeDFT
Date Initiated2005-11-10
Date Terminated2007-03-20
Product Quantity1275 (212 in US)

Reason for Recall

These specific protein assays are not meeting the 57-day on board stability claim

Firm 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..

Root Cause

Other

Distribution Pattern

Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983132IGMAbbott Laboratories · 1998-11-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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