Z-1204-06

ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100...

Name: Z-1204-06 ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100...
Creator: Abbott Laboratories MPG
Published: 2006-06-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-06-06 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories MPG began a recall of ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott... on 2006-06-06. The reason FDA records is "Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1204-06
Status: Terminated
Initiated: 2006-06-06
Posted: 2006-07-04
Terminated: 2008-01-18
Recalling firm: Abbott Medical
Product: ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
Product code: DBF Ferritin, Antigen, Antiserum, Control
Reason for recall: Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Abbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachment A when they change to the assay materials manufactured using the new internal reference standards. The accounts were requested to keep a copy of the letter on file until the revised package insert is received.
Quantity in commerce: 10,725 kits
Distribution: Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand
Product codes and lots: list numbers 6C11-20, 6C11-25 and 6C11-30; all lots

Product code DBF

K983759Class IIAbbott Architect FerritinAbbott Laboratories / cleared 1998-12-07

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)