Z-1452-04

ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories...

Name: Z-1452-04 ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2004-08-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-08-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2... on 2004-08-19. The reason FDA records is "Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1452-04
Status: Terminated
Initiated: 2004-08-19
Posted: 2004-09-14
Terminated: 2005-07-29
Recalling firm: Abbott Medical
Product: ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany
Product code: LIG Radioassay, Intrinsic Factor Blocking Antibody
Reason for recall: Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan were e-mailed copies of the recall letter on 8/19/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for changes in the reagents over time that affect the shape of the calibration curve, producing controls out of range low and similar decreases in patient sample values. The accounts were instructed to manually update the expiration dates for the reagent lots according to the chart given in the recall letter for any of the affected lots remaining in inventory. The expiration date reported by the Architect instrument must also be manually updated.
Quantity in commerce: 5754 kits
Distribution: Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.
Product codes and lots: List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300; List 6C09-25, lots 11002M301, 16051M201, 18288M301

Product code LIG

K984108Class IIAbbott Architect B12Abbott Laboratories / cleared 1999-02-03

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)