Z-0860-06

ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit...

Name: Z-0860-06 ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit...
Creator: Abbott Laboratories MPG
Published: 2006-03-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-03-08 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories MPG began a recall of ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay... on 2006-03-08. The reason FDA records is "The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT...". 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-0860-06
Status: Terminated
Initiated: 2006-03-08
Posted: 2006-05-11
Terminated: 2006-07-31
Recalling firm: Abbott Medical
Product: ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
Product code: LIG Radioassay, Intrinsic Factor Blocking Antibody
Reason for recall: The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Abbott affiliates in Canada, Germany and Australia were e-mailed copies of the recall letter on 3/8/06 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised that the 30-day onboard storage information is not included in the barcode for the two lots. As a result the ARCHITECT system software is unable to track how long the reagent kit has been stored onboard. The accounts were instructed to manually track the onboard storage time for the two lots, and discard the kits after 30 days of onboard storage.
Quantity in commerce: 135 kits
Distribution: Canada, Germany and Australia
Product codes and lots: lot numbers 33079M200, 33079M201

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)