Z-0783-05

ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500...

Name: Z-0783-05 ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500...
Creator: Abbott Laboratories MPG
Published: 2005-03-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-03-11 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories MPG began a recall of ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064... on 2005-03-11. The reason FDA records is "concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert". 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-0783-05
Status: Terminated
Initiated: 2005-03-11
Posted: 2005-04-28
Terminated: 2006-01-18
Recalling firm: Abbott Medical
Product: ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.
Quantity in commerce: 2,521 kits
Distribution: Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia
Product codes and lots: lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100

Product code CGN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)