Z-0384-06

Clinical Chemistry Immunoglobulin M, List Number 1E01-20

Name: Z-0384-06 Clinical Chemistry Immunoglobulin M, List Number 1E01-20
Creator: Abbott Laboratories Diagnostic Div
Published: 2005-11-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-11-10 / Terminated

FDA source

Abbott Laboratories Diagnostic Div began a recall of Clinical Chemistry Immunoglobulin M, List Number 1E01-20 on 2005-11-10. The reason FDA records is "These specific protein assays are not meeting the 57-day on board stability claim". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0384-06
Status: Terminated
Initiated: 2005-11-10
Posted: 2006-01-11
Terminated: 2007-03-20
Recalling firm: Abbott Medical
Product: Clinical Chemistry Immunoglobulin M, List Number 1E01-20
Product code: DFT Igm, Antigen, Antiserum, Control
Reason for recall: These specific protein assays are not meeting the 57-day on board stability claim
FDA root cause: 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: 1275 (212 in US)
Distribution: Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand
Product codes and lots: Lot Number(s): 30067HW00, 27057HW00, & 23026HW00

Product code DFT

K983132Class IIIgmAbbott Laboratories / cleared 1998-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)